Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00288639
First received: February 7, 2006
Last updated: August 28, 2009
Last verified: August 2009
Results First Received: December 16, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: Pregabalin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Planned to enroll approximately 100 subjects with partial seizures at up to 10 study centers in Greece.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Single arm open label study without randomization. The study included the following 3 main phases with a total study treatment duration of up to 21 weeks: Treatment dose-optimization phase = 9 weeks. Treatment observation phase = 12 weeks.

Reporting Groups
  Description
Pregabalin Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).

Participant Flow:   Overall Study
    Pregabalin  
STARTED     98  
COMPLETED     86  
NOT COMPLETED     12  
Adverse Event                 5  
Lack of Efficacy                 4  
Withdrawal by Subject                 2  
Unknown                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pregabalin Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  98  
Age, Customized  
[units: Participants]
 
18 to 44 years     69  
45 to 64 years     25  
>=65 years     4  
Gender  
[units: participants]
 
Female     49  
Male     49  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period   [ Time Frame: 8 week baseline period & 12 week treatment observation period ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
Measure Description Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period).
Time Frame 8 week baseline period & 12 week treatment observation period  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency.

Reporting Groups
  Description
Pregabalin Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).

Measured Values
    Pregabalin  
Number of Participants Analyzed  
[units: participants]
  92  
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period  
[units: percentage change in events]
Median ( Full Range )
  -33.33  
  ( -100.00 to 7566.67 )  


Statistical Analysis 1 for Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period
Groups [1] Pregabalin
Mean Response Ratio [2] -22.72
Standard Deviation ± 55.232
95% Confidence Interval ( -34.16 to -11.28 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.
[2] Other relevant estimation information:
  Response ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.



2.  Secondary:   Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period.   [ Time Frame: 8 week baseline period and 21 week treatment period ]

3.  Secondary:   Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period.   [ Time Frame: 8 week baseline period and 21 week treatment period ]

4.  Secondary:   Number of Subjects Seizure-free   [ Time Frame: last 4 weeks & whole 12 week treatment observation period ]

5.  Secondary:   Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period.   [ Time Frame: 8 week baseline observation period & last 4 weeks of observation period ]

6.  Secondary:   Subjects Achieving Seizure Freedom During Observation Period   [ Time Frame: Day 147 from the first dose of study drug ]

7.  Secondary:   Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency   [ Time Frame: 8 week baseline observation period & 12 week treatment observation period ]

8.  Secondary:   Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC)   [ Time Frame: End of 21-week treatment ]

9.  Secondary:   Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC)   [ Time Frame: End of 21-week treatment ]

10.  Secondary:   Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores   [ Time Frame: Baseline, end of 21-week treatment ]

11.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21.   [ Time Frame: Baseline, End of 21-week treatment ]

12.  Secondary:   Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline   [ Time Frame: Baseline, End of 21-week treatment ]

13.  Secondary:   Subjects Assessment of Optimal Sleep   [ Time Frame: Baseline, End of 21-week treatment ]

14.  Post-Hoc:   Change in Partial Seizure Frequency by Type Between the 8 Week Baseline Period and During the 12 Week Observation Period.   [ Time Frame: 8 week baseline period & 12 week treatment observation period ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00288639     History of Changes
Other Study ID Numbers: A0081088
Study First Received: February 7, 2006
Results First Received: December 16, 2008
Last Updated: August 28, 2009
Health Authority: Greece: National Organization of Medicines