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Once-A-Day Pregabalin For Partial Seizures

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ClinicalTrials.gov Identifier: NCT01262677
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : June 5, 2018
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Partial Seizures
Epilepsies, Partial
Interventions Drug: pregabalin
Drug: placebo
Enrollment 325
Recruitment Details This was a multicenter, multinational study and included four standard phases: an 8-week baseline observation phase, a 2-week dose escalation phase, a 12-week fixed-dose maintenance phase, and a 1-week taper phase.
Pre-assignment Details An 8-week baseline observation phase began immediately after the screening visit. Througout the observation phase the participants continued their current anti-epileptic drugs (AEDs) at the prescribed dosage, eligibility was re-evaluated at Week -4 and Week 0, and the participants recorded all seizures in daily seizure diaries.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hour (hr) after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Period Title: Overall Study
Started 100 113 110
Completed 91 98 98
Not Completed 9 15 12
Reason Not Completed
Does not meet entrance criteria             0             2             0
Insufficient clinical response             0             0             1
Lost to Follow-up             1             0             2
No longer willing to participate             3             3             2
Reason not provided             2             1             3
Protocol Violation             0             1             1
Adverse Event (AE) related to study drug             3             8             3
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo Total
Hide Arm/Group Description After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. Total of all reporting groups
Overall Number of Baseline Participants 100 113 110 323
Hide Baseline Analysis Population Description
The safety analysis set included all randomized participants who took at least one dose of the study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 113 participants 110 participants 323 participants
37.88  (13.10) 39.58  (13.15) 38.72  (13.25) 38.76  (13.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 113 participants 110 participants 323 participants
Female
53
  53.0%
55
  48.7%
61
  55.5%
169
  52.3%
Male
47
  47.0%
58
  51.3%
49
  44.5%
154
  47.7%
1.Primary Outcome
Title Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase
Hide Description Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame Week 0 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 112 109
Mean (Standard Deviation)
Unit of Measure: ln (seizures per 28 days)
Baseline Number Analyzed 100 participants 112 participants 109 participants
2.24  (0.757) 2.33  (0.873) 2.32  (0.910)
Week 14 Number Analyzed 98 participants 111 participants 109 participants
1.84  (1.003) 1.80  (1.030) 1.93  (1.132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9076
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-16.28 to 17.11
Estimation Comments Value is percent reduction in seizures relative to placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0907
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -13.05
Confidence Interval (2-Sided) 95%
-26.07 to 2.25
Estimation Comments Value is percent reduction in seizures relative to placebo.
2.Secondary Outcome
Title Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase
Hide Description Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder.
Time Frame Week 0 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 98 111 109
Measure Type: Number
Unit of Measure: percentage of participants
Responder 37.8 45.9 35.8
Non-responder 62.2 54.1 64.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.752
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase
Hide Description Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame Week 0 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 98 111 109
Least Squares Mean (Standard Error)
Unit of Measure: ln (seizures per 28 days)
-15.00  (11.668) -31.54  (10.772) -5.70  (10.918)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model was used to calculate the p-value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5404
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.30
Confidence Interval (2-Sided) 95%
-39.16 to 20.56
Estimation Comments Value is percent reduction in seizures relative to placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model was used to calculate the p-value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0786
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -25.84
Confidence Interval (2-Sided) 95%
-54.64 to 2.97
Estimation Comments Value is percent reduction in seizures relative to placebo.
4.Secondary Outcome
Title Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase
Hide Description Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Time Frame Week 0 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 98 111 109
Mean (Standard Deviation)
Unit of Measure: seizures per 28 days
3.99  (8.667) 4.43  (14.736) 7.51  (24.979)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6073
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method Generalized linear model (GLM)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.53 to 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4109
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method GLM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-0.53 to 0.22
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase
Hide Description Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame Week 2 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 96 110 109
Least Squares Mean (Standard Error)
Unit of Measure: ln (seizures per 28 days)
0.46  (0.049) 0.48  (0.045) 0.48  (0.046)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8268
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-12.97 to 11.75
Estimation Comments Value is percent reduction in seizures relative to placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9024
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
-10.69 to 13.66
Estimation Comments Value is percent reduction in seizures relative to placebo.
6.Secondary Outcome
Title Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase
Hide Description Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.
Time Frame Week 0 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 96 108 105
Measure Type: Number
Unit of Measure: percentage of participants
1.0 1.9 1.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase
Hide Description Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.
Time Frame Week 2 to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 96 110 109
Least Squares Mean (Standard Error)
Unit of Measure: ln(28-day seizure rate)
1.91  (0.070) 1.77  (0.064) 1.88  (0.065)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8034
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.28
Confidence Interval (2-Sided) 95%
-14.37 to 22.15
Estimation Comments Value is percent reduction in seizures relative to placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1905
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.78
Confidence Interval (2-Sided) 95%
-24.81 to 5.87
Estimation Comments Value is percent reduction in seizures relative to placebo.
8.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14
Hide Description HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (3.34) -0.4  (3.19) -0.5  (3.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4650
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.1 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9692
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.8 to 0.8
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14
Hide Description HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (3.16) -0.8  (3.49) -0.1  (3.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2693
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.3 to 0.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1893
Comments Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.4 to 0.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.9  (19.89) -1.5  (17.93) -1.9  (14.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7347
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-5.2 to 3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8971
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-4.0 to 4.6
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in MOS-SS - Snoring Score at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 92 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.5  (25.44) 5.4  (26.00) -0.6  (22.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3972
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-9.1 to 3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0319
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
0.6 to 12.9
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (20.75) 1.0  (24.48) -0.8  (18.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7708
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-4.4 to 5.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3560
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-2.7 to 7.4
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 92 103 100
Mean (Standard Deviation)
Unit of Measure: hours
0.2  (1.31) -0.1  (1.18) -0.1  (1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1129
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9388
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.3 to 0.3
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (31.14) -1.7  (31.44) -1.5  (24.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9053
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-7.5 to 6.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6371
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-8.5 to 5.2
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (17.29) 5.2  (19.42) 5.0  (18.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.4
Confidence Interval (2-Sided) 95%
-11.4 to -1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9909
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.9 to 4.8
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.2  (16.91) 0.4  (16.43) 0.3  (12.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5903
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-5.0 to 2.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7126
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-3.1 to 4.5
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14
Hide Description Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame Baseline, Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (15.62) 0.7  (14.53) 0.7  (11.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2431
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-5.8 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8654
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-3.2 to 3.8
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale
Hide Description Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 93 103 103
Measure Type: Number
Unit of Measure: percentage of participants
67.7 60.2 60.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin 165 mg, Placebo
Comments Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3241
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.74 to 2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pregabalin 330 mg, Placebo
Comments Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8932
Comments Statistical testing was done at alpha = 0.05 level, two-sided.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.54 to 1.71
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question
Hide Description The BSW consisted of 3 single-item measures designed to capture the participant’s perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 112 109
Measure Type: Number
Unit of Measure: percentage of participants
No 12.0 17.9 22.0
Little benefit 31.0 23.2 33.0
Much benefit 54.0 56.3 42.2
Not done 2.0 1.8 1.8
Missing 1.0 0.9 0.9
20.Secondary Outcome
Title BSW: Satisfaction From Treatment Question
Hide Description The BSW consisted of 3 single-item measures designed to capture the participant’s perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 112 109
Measure Type: Number
Unit of Measure: percentage of participants
No 13.0 17.9 23.9
Yes 84.0 80.4 73.4
Missing 3.0 1.8 2.8
21.Secondary Outcome
Title BSW: Willingness to Continue Question
Hide Description The BSW consisted of 3 single-item measures designed to capture the participant`s perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 112 109
Measure Type: Number
Unit of Measure: percentage of participants
No 18.0 22.3 26.6
Yes 79.0 75.9 70.6
Missing 3.0 1.8 2.8
22.Secondary Outcome
Title Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase
Hide Description Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.
Time Frame Day 1 to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 113 110
Measure Type: Number
Unit of Measure: percentage of participants
General 1.0 2.7 0.0
Skin 2.0 6.2 4.5
Head 1.0 1.8 0.0
Ears 3.0 1.8 0.9
Eyes 1.0 2.7 3.6
Nose 0.0 0.0 1.8
Throat 0.0 0.0 1.8
Lungs 0.0 0.0 0.0
Heart 1.0 0.0 0.0
Abdomen 0.0 0.0 0.0
Extremities 2.0 2.7 1.8
Other 14.0 7.1 10.9
23.Secondary Outcome
Title Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase
Hide Description Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait.
Time Frame Day 1 to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 113 110
Measure Type: Number
Unit of Measure: percentage of participants
None Number Analyzed 100 participants 113 participants 110 participants
79.0 78.8 68.2
Any Number Analyzed 100 participants 113 participants 110 participants
21.0 21.2 31.8
Coordination Number Analyzed 100 participants 113 participants 110 participants
1.0 1.8 1.8
Cranial nerve function Number Analyzed 99 participants 111 participants 108 participants
0.0 0.9 0.0
Cranial nerve II Number Analyzed 99 participants 111 participants 108 participants
0.0 0.0 0.0
Cranial nerve III Number Analyzed 100 participants 113 participants 110 participants
0.0 0.0 1.8
Cranial nerve V Number Analyzed 99 participants 111 participants 108 participants
0.0 0.0 0.0
Cranial nerve VII Number Analyzed 99 participants 111 participants 108 participants
1.0 0.0 0.9
Cranial nerve VIII Number Analyzed 99 participants 111 participants 108 participants
0.0 0.9 0.0
Cranial nerve XI Number Analyzed 99 participants 111 participants 108 participants
0.0 0.0 0.0
Deep tendon reflexes Number Analyzed 100 participants 113 participants 110 participants
3.0 1.8 2.7
Gait and station Number Analyzed 100 participants 113 participants 110 participants
0.0 0.0 0.9
Level of consciousness Number Analyzed 100 participants 113 participants 110 participants
0.0 0.0 0.9
Mental state Number Analyzed 100 participants 113 participants 110 participants
1.0 1.8 1.8
Motor function Number Analyzed 100 participants 113 participants 110 participants
1.0 2.7 3.6
Muscle strength Number Analyzed 99 participants 111 participants 108 participants
2.0 0.0 1.9
Pain sensation Number Analyzed 99 participants 111 participants 108 participants
0.0 0.0 1.9
Reflexes Number Analyzed 99 participants 111 participants 108 participants
1.0 0.9 1.9
Vibration Number Analyzed 99 participants 111 participants 108 participants
11.1 10.8 12.0
24.Secondary Outcome
Title Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Hide Description C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events.
Time Frame Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 113 110
Measure Type: Number
Unit of Measure: percentage of participants
Suicide attempt (Lifetime prior to Screening) 2.0 1.8 5.5
PAISB (Lifetime prior to Screening) 1.0 1.8 4.5
Suicidal ideation (Lifetime prior to Screening) 11.0 10.6 14.5
SIB-NSI (Lifetime prior to Screening) 1.0 0.9 0.9
Suicide attempts at Week 0 1.0 0.9 0.0
PAISB at Week 0 0.0 0.9 0.0
Suicidal ideation at Week 0 8.0 7.1 2.7
SIB-NSI at Week 0 1.0 0.0 0.0
Suicidal ideation at Week 14 4.0 2.7 1.8
25.Secondary Outcome
Title Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase
Hide Description Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema).
Time Frame Day 1 to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 99 110 108
Measure Type: Number
Unit of Measure: percentage of participants
Maximum increase in systolic BP ≥30 mmHg 1.0 1.8 0.9
Maximum increase in diastolic BP ≥20 mmHg 5.1 5.5 2.8
26.Secondary Outcome
Title Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms
Hide Description The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated.
Time Frame Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 113 110
Measure Type: Number
Unit of Measure: percentage of participants
Maximum QTcB 450 - <480 8.0 5.3 10.0
Maximum QTcB 480 - <500 1.0 0.0 0.9
Maximum QTcB ≥500 0.0 1.8 0.0
Maximum QTcF 450 - <480 3.0 2.7 3.6
Maximum QTcF 480 - <500 1.0 0.0 0.0
Maximum QTcF ≥500 0.0 0.0 0.0
27.Secondary Outcome
Title Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase
Hide Description The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR.
Time Frame Week 15
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Hide Analysis Population Description
The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 100 113 110
Measure Type: Number
Unit of Measure: percentage of participants
Max PR interval rise:%change≥25/50% Number Analyzed 92 participants 104 participants 96 participants
1.1 1.0 2.1
Max QRS complex rise:%change≥25/50% Number Analyzed 92 participants 104 participants 96 participants
1.1 1.9 1.0
Max. QTcB interval rise: 30≤x<60 Number Analyzed 93 participants 104 participants 97 participants
5.4 1.9 3.1
Max. QTcB interval rise: ≥60 Number Analyzed 93 participants 104 participants 97 participants
0.0 1.9 0.0
Max. QTcF interval rise: 30≤x<60 Number Analyzed 93 participants 104 participants 97 participants
3.2 1.9 2.1
Max. QTcF interval rise: ≥60 Number Analyzed 93 participants 104 participants 97 participants
0.0 0.0 0.0
28.Secondary Outcome
Title Percentage of Participants With Laboratory Test Abnormalities During the Study
Hide Description Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen
Time Frame Day 1 to Week 15
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Hide Analysis Population Description
The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description:
After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
Overall Number of Participants Analyzed 99 111 108
Measure Type: Number
Unit of Measure: percentage of participants
Hemoglobin (HGB) <0.8xLLN , Number Analyzed 98 participants 109 participants 107 participants
1.0 0.9 0.9
Hematocrit (HCT) <0.8xLLN Number Analyzed 96 participants 107 participants 107 participants
0.0 0.9 0.0
RBC Count <0.8xLLN Number Analyzed 98 participants 109 participants 107 participants
0.0 0.0 0.0
Platelets <0.5xLLN Number Analyzed 95 participants 108 participants 105 participants
0.0 0.0 0.0
Platelets >1.75xULN Number Analyzed 95 participants 108 participants 105 participants
0.0 0.0 0.0
WBC Count <0.6xLLN Number Analyzed 98 participants 109 participants 107 participants
0.0 0.9 0.0
White Blood Cell Count >1.5xULN Number Analyzed 98 participants 109 participants 107 participants
0.0 0.0 0.0
Lymphocytes (absolute) <0.8xLLN Number Analyzed 96 participants 109 participants 106 participants
4.2 0.9 1.9
Lymphocytes (absolute) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
2.1 1.8 3.8
Lymphocytes (%) <0.8xLLN Number Analyzed 96 participants 109 participants 106 participants
0.0 0.0 1.9
Lymphocytes (%) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
1.0 0.0 0.9
Neutrophils (absolute) <0.8xLLN Number Analyzed 96 participants 109 participants 106 participants
3.1 1.8 1.9
Neutrophils (absolute) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
0.0 0.0 1.9
Neutrophils (%) <0.8xLLN Number Analyzed 96 participants 109 participants 106 participants
1.0 0.0 0.0
Neutrophils (%) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
0.0 0.0 0.0
Basophils (absolute) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
0.0 0.0 0.0
Basophils (%) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
0.0 0.0 0.0
Eosinophils (absolute) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
3.1 3.7 1.9
Eosinophils (%) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
6.3 4.6 3.8
Monocytes (absolute) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
0.0 1.8 0.0
Monocytes (%) >1.2xULN Number Analyzed 96 participants 109 participants 106 participants
1.0 0.0 0.0
Total Bilirubin >1.5xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
AST >3.0xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
ALT >3.0xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Alkaline Phosphatase >3.0xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Total Protein <0.8xLLN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Total Protein >1.2xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Albumin <0.8xLLN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Albumin >1.2xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
BUN >1.3xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Creatinine >1.3xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Uric Acid >1.2xULN Number Analyzed 98 participants 111 participants 107 participants
1.0 0.9 0.0
Sodium <0.95xLLN Number Analyzed 97 participants 111 participants 106 participants
1.0 0.0 0.0
Sodium >1.05xULN Number Analyzed 97 participants 111 participants 106 participants
0.0 0.0 0.0
Potassium <0.9xLLN Number Analyzed 98 participants 111 participants 107 participants
2.0 0.0 0.0
Potassium >1.1xULN Number Analyzed 98 participants 111 participants 107 participants
1.0 0.0 0.0
Chloride <0.9xLLN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Chloride >1.1xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Calcium <0.9xLLN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Calcium >1.1xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Glucose <0.6xLLN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.0 0.0
Glucose >1.5xULN Number Analyzed 98 participants 111 participants 107 participants
0.0 0.9 0.0
Urine Specific Gravity <1.003 Number Analyzed 92 participants 104 participants 104 participants
0.0 1.9 1.0
Urine Specific Gravity >1.030 Number Analyzed 92 participants 104 participants 104 participants
1.1 1.9 4.8
Urine pH <4.5 Number Analyzed 93 participants 105 participants 104 participants
0.0 0.0 0.0
Urine pH >8 Number Analyzed 93 participants 105 participants 104 participants
1.1 1.9 1.9
Urine Glucose (qualitative) ≥1 Number Analyzed 94 participants 106 participants 105 participants
0.0 0.9 0.0
Urine Ketones (qualitative) ≥1 Number Analyzed 94 participants 106 participants 105 participants
2.1 1.9 1.9
Urine Protein (qualitative) ≥1 Number Analyzed 94 participants 106 participants 105 participants
3.2 2.8 1.0
Urine Blood/Hgb (qualitative) ≥1 Number Analyzed 94 participants 106 participants 105 participants
8.5 9.4 9.5
Urine Nitrite ≥1 Number Analyzed 94 participants 105 participants 105 participants
11.7 5.7 13.3
Urine RBC ≥20 Number Analyzed 15 participants 26 participants 21 participants
13.3 0.0 9.5
Urine WBC ≥20 Number Analyzed 21 participants 27 participants 27 participants
4.8 3.7 29.6
Time Frame From the time the participant provided informed consent, which was obtained prior to the participant`s participation in the study, through and including 28 calendar days after the last administration of the investigational product.
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one particpant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Pregabalin 165 mg Pregabalin 330 mg Placebo
Hide Arm/Group Description After the 2-week dose escalation phase, the participants received 165 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. After the 2-week dose escalation phase, the participants received 330 mg of pregabalin once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing. After the 2-week dose escalation phase, the participants received placebo once a day during the 12-week double-blind maintenance phase. Afterwards, the study medication was tapered for one week. The tablets were to be taken orally, within 1 hr after the evening meal. The medication must have been taken intact and not bitten, chewed, cut, or otherwise altered prior to swallowing.
All-Cause Mortality
Pregabalin 165 mg Pregabalin 330 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin 165 mg Pregabalin 330 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/100 (5.00%)   5/113 (4.42%)   2/110 (1.82%) 
Infections and infestations       
Bronchitis * 1  1/100 (1.00%)  0/113 (0.00%)  0/110 (0.00%) 
Pneumonia * 1  1/100 (1.00%)  0/113 (0.00%)  0/110 (0.00%) 
Subcutaneous abscess * 1  0/100 (0.00%)  1/113 (0.88%)  0/110 (0.00%) 
Viral infection * 1  1/100 (1.00%)  0/113 (0.00%)  0/110 (0.00%) 
Injury, poisoning and procedural complications       
Wound * 1  0/100 (0.00%)  0/113 (0.00%)  1/110 (0.91%) 
Nervous system disorders       
Ataxia * 1  0/100 (0.00%)  1/113 (0.88%)  0/110 (0.00%) 
Complex partial seizures * 1  1/100 (1.00%)  0/113 (0.00%)  0/110 (0.00%) 
Convulsion * 1  1/100 (1.00%)  1/113 (0.88%)  1/110 (0.91%) 
Epilepsy * 1  1/100 (1.00%)  0/113 (0.00%)  0/110 (0.00%) 
Grand mal convulsion * 1  1/100 (1.00%)  0/113 (0.00%)  0/110 (0.00%) 
Myoclonus * 1  0/100 (0.00%)  1/113 (0.88%)  0/110 (0.00%) 
Somnolence * 1  0/100 (0.00%)  1/113 (0.88%)  0/110 (0.00%) 
Psychiatric disorders       
Anxiety * 1  0/100 (0.00%)  1/113 (0.88%)  0/110 (0.00%) 
Hallucination * 1  0/100 (0.00%)  1/113 (0.88%)  0/110 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin 165 mg Pregabalin 330 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/100 (14.00%)   21/113 (18.58%)   3/110 (2.73%) 
General disorders       
Fatigue * 1  3/100 (3.00%)  6/113 (5.31%)  1/110 (0.91%) 
Investigations       
Weight increased * 1  1/100 (1.00%)  7/113 (6.19%)  0/110 (0.00%) 
Nervous system disorders       
Dizziness * 1  11/100 (11.00%)  11/113 (9.73%)  2/110 (1.82%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01262677     History of Changes
Other Study ID Numbers: A0081194
2010-019035-35 ( EudraCT Number )
First Submitted: December 16, 2010
First Posted: December 17, 2010
Results First Submitted: October 16, 2017
Results First Posted: June 5, 2018
Last Update Posted: June 5, 2018