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Vision Testing in Patients With Partial Seizures Receiving Either Lyrica or Placebo

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ClinicalTrials.gov Identifier: NCT00351611
Recruitment Status : Completed
First Posted : July 13, 2006
Results First Posted : February 21, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Epilepsies, Partial
Interventions Drug: Lyrica (pregabalin)
Drug: placebo
Enrollment 187
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 milligram per day (mg/day) as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study. Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
Period Title: Overall Study
Started 89 98
Treated 89 98
Completed 75 88
Not Completed 14 10
Reason Not Completed
Adverse Event             11             3
Death             1             0
Lost to Follow-up             1             0
No Longer Willing to Participate in Study             0             5
Other             1             0
Protocol Violation             0             2
Arm/Group Title Pregabalin Placebo Total
Hide Arm/Group Description Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study. Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15. Total of all reporting groups
Overall Number of Baseline Participants 89 98 187
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants randomized to treatment, who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 98 participants 187 participants
38.1  (12.1) 39.1  (11.6) 38.6  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 98 participants 187 participants
Female
44
  49.4%
46
  46.9%
90
  48.1%
Male
45
  50.6%
52
  53.1%
97
  51.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 89 participants 98 participants 187 participants
White
47
  52.8%
51
  52.0%
98
  52.4%
Black
4
   4.5%
5
   5.1%
9
   4.8%
Asian
34
  38.2%
40
  40.8%
74
  39.6%
Others
4
   4.5%
2
   2.0%
6
   3.2%
1.Primary Outcome
Title Percentage of Participants With a Decrease (p<0.05) From Baseline in Threshold Value in Any 5 or More Points in Humphrey 24-2 Swedish Interactive Threshold Algorithm (SITA) Standard Testing at Week 12 or Early Termination
Hide Description In this primary outcome measure, percentage of participants is reported, with a decrease in the threshold value from baseline to Week 12 or termination in any 5 or more points (in either eye) at the p<0.05 level repeated in the same 5 points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard). It was derived from the Humphrey 24-2 SITA standard visual field analyzer. For each eye there were 52 test points. For each test point, the Humphrey analyzer determined the threshold value for sensitivity to light by the participant. In addition, for each of the 52 points, the test provided probabilities (p<0.05, p<0.02, etc.) that a participant with normal vision of the same age would have the same result, i.e., that the measured value at that point was at or below the respective percentile of the age-specific empiric distribution at that position of the field for normal participants.
Time Frame Baseline, Week 12 or Early Termination (any time up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population included all participants randomized to treatment who received at least 1 dose of study medication and excluded participants who had a decrease in at least 5 points at termination but did not return for a repeat test.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
Overall Number of Participants Analyzed 78 90
Measure Type: Number
Unit of Measure: Percentage of participants
3.8 5.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments A 2-sided 95 percent (%) confidence interval (CI) on the difference in percentage of participants, between pregabalin and placebo was constructed using unconditional exact methods.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was demonstrated if the upper CI bound was less than 0.10 (10%).
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -1.7094
Confidence Interval (2-Sided) 95%
-9.1751 to 5.9784
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Deviation Score From Humphrey Threshold Test at Week 12 or Early Termination
Hide Description Mean deviation (MD) is a global index of visual field depression. The MD ranges from 0 decibels (no defect) to about -32 decibels (end-stage damage), higher scores indicate worse condition. It is derived from the Humphrey 24-2 SITA standard visual field analyzer. Change in mean deviation score from baseline to Week 12 or termination was computed for each participant. As planned, for each participant, the worst eye (eye with the greatest decrease in mean deviation) was used in the analysis and data is reported for same.
Time Frame Baseline, Week 12 or Early Termination (any time up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to treatment, who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" refers to those participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
Overall Number of Participants Analyzed 83 96
Least Squares Mean (Standard Error)
Unit of Measure: Decibels
-0.339  (0.1467) -0.214  (0.1321)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments Analysis of covariance (ANCOVA) with treatment and center in the model and the baseline mean deviation as the covariate was used to construct a 2-sided 95% CI on the difference in least squares (LS) mean between pregabalin and placebo.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority with respect to mean deviation was demonstrated if the lower bound of the CI is greater than -2.0 decibels.
Statistical Test of Hypothesis P-Value 0.4414
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -0.125
Confidence Interval (2-Sided) 95%
-0.443 to 0.194
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Visual Acuity at Week 12 or Early Termination
Hide Description Visual acuity best-corrected (with glasses or best possible glasses prescription) was measured using early treatment diabetic retinopathy study (ETDRS) charts. There were 2 ETDRS charts. The letters on chart A were read using the right eye and on chart B using the left eye. The participants started from the top of the chart to down. The participants read down the chart until they reached a row where a minimum of 3 letters on a line could not be read. The participants were scored by number of letters identified correctly. Range was from 0 to 70, with higher scores indicate better visual acuity. As planned, for each participant, the worst eye (eye with the greatest decrease in visual acuity) was used in the analysis and data is reported for same.
Time Frame Baseline, Week 12 or Early Termination (any time up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized to treatment, who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" refers to those participants who were evaluable for this outcome measure.
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description:
Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study.
Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
Overall Number of Participants Analyzed 83 94
Least Squares Mean (Standard Error)
Unit of Measure: Letters identified correctly
-1.890  (0.5515) -0.990  (0.5057)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pregabalin, Placebo
Comments ANCOVA with treatment and center in the model and the baseline visual acuity as the covariate was used to construct a 2-sided 95% confidence interval on the difference in LS mean between pregabalin and placebo.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1346
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -0.900
Confidence Interval (2-Sided) 95%
-2.083 to 0.283
Estimation Comments [Not Specified]
Time Frame Baseline up to Week 15
Adverse Event Reporting Description Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis performed on all participants randomized to treatment, who received at least 1 dose of study medication.
 
Arm/Group Title Pregabalin Placebo
Hide Arm/Group Description Participants were randomized to receive pregabalin. In Week 1 (titration), participants received pregabalin 150 mg/day as 75 mg oral capsules twice daily. From Week 2 to 12, participants received pregabalin 300 mg/day as 150 mg oral capsules twice daily. In Week 13 (tapering), participants received 150 mg/day as 75 mg oral capsules twice daily. Participants were followed up from Week 14 to 15. If participants not tolerated 300 mg/day dose, they were discontinued from the study. Participants were randomized to receive placebo matched to pregabalin from Week 1 to 13 and were followed up from Week 14 to 15.
All-Cause Mortality
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/89 (1.12%)   0/98 (0.00%) 
Hide Serious Adverse Events
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/89 (4.49%)   1/98 (1.02%) 
Infections and infestations     
Pneumonia * 1  1/89 (1.12%)  0/98 (0.00%) 
Nervous system disorders     
Generalised tonic-clonic seizure * 1  1/89 (1.12%)  0/98 (0.00%) 
Postictal state * 1  1/89 (1.12%)  0/98 (0.00%) 
Status epilepticus * 1  1/89 (1.12%)  0/98 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy * 1  0/89 (0.00%)  1/98 (1.02%) 
Psychiatric disorders     
Major depression * 1  1/89 (1.12%)  0/98 (0.00%) 
Suicidal ideation * 1  1/89 (1.12%)  0/98 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  1/89 (1.12%)  0/98 (0.00%) 
1
Term from vocabulary, MedDRA v23.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Pregabalin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   33/89 (37.08%)   13/98 (13.27%) 
General disorders     
Fatigue * 1  6/89 (6.74%)  3/98 (3.06%) 
Investigations     
Weight increased * 1  5/89 (5.62%)  2/98 (2.04%) 
Nervous system disorders     
Dizziness * 1  20/89 (22.47%)  3/98 (3.06%) 
Headache * 1  3/89 (3.37%)  5/98 (5.10%) 
Somnolence * 1  7/89 (7.87%)  3/98 (3.06%) 
1
Term from vocabulary, MedDRA v23.1
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
ClinicalTrials.gov Identifier: NCT00351611    
Other Study ID Numbers: A0081096
2009-014269-25 ( EudraCT Number )
First Submitted: July 11, 2006
First Posted: July 13, 2006
Results First Submitted: February 1, 2021
Results First Posted: February 21, 2021
Last Update Posted: April 13, 2021