Clinical Trial: Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures
Brief Summary: The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase [ Time Frame: Week 5 up to Week 56 ]
Original Primary Outcome: Proportion of patients seizure-free for 6 months during the efficacy assessment phase (excluding dose escalation phase).
Current Secondary Outcome:
- Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures [ Time Frame: Week 4 up to Week 56 ]Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.
- Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase) [ Time Frame: Week 0 to Week 56 ]Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.
- Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase) [ Time Frame: Week 0 to Week 56 ]Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.
- Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase [ Time Frame: Week 4 up to Week 56 ]Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.
- Exit Due to Any Reason After 4-week Dose Escalation Phase [ Time Frame: Week 4 up to Week 56 ]Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.
- Time to First Seizure After the 4-Week Dose Escalation Phase [ Time Frame: Week 4 up to Week 56 ]Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.
- Median Monthy Seizure Frequency: All Partial Seizures [ Time Frame: Baseline up to Week 60 ]All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
- Mean Monthy Seizure Frequency: All Partial Seizures [ Time Frame: Baseline up to Week 60 ]All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
- Median Monthy Seizure Frequency: All Seizures [ Time Frame: Baseline up to Week 60 ]Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
- Mean Monthy Seizure Frequency: All Seizures [ Time Frame: Baseline up to Week 60 ]Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
- Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ]All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures
Original Secondary Outcome: Time to exit due to adverse events during the double-blind treatment period (including dose escalation phase). Time to 6-months seizure-freedom after the dose escalation phase. Time to exit due to lack of efficacy after the dose escalation phase. Time to
Information By: Pfizer
Dates:
Date Received: January 18, 2006
Date Started: August 2006
Date Completion:
Last Updated: March 4, 2015
Last Verified: March 2015
