Clinical Trial: Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures

Brief Summary: This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.

Detailed Summary: The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase.
Sponsor: GlaxoSmithKline

Current Primary Outcome: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) [ Time Frame: From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23) ]

The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.


Original Primary Outcome: Proportion of subjects in the 300 mg/day arm who prematurely discontinue the study.

Current Secondary Outcome:

  • The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) [ Time Frame: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) ]
    The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.
  • Time to Discontinuation in the Treatment Phase [ Time Frame: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) ]
    Time (days) until the participant discontinued the study
  • Percentage of Participants Meeting Escape Criteria in the Treatment Phase [ Time Frame: Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) ]
    The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.
  • Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase) [ Time Frame: Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23) ]
    Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.
  • Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase [ Time Frame: The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23) ]
    The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn
  • Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase [ Time Frame: Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase ]
    Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.
  • The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks) [ Time Frame: Baseline and entire Continuation phase (24 Weeks) ]
    Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.


Original Secondary Outcome: Time to discontinuation after escalation Percent change from baseline seizure frequency Proportion of subjects in the 250 mg/day treatment group who prematurely discontinue.

Information By: GlaxoSmithKline

Dates:
Date Received: July 19, 2006
Date Started: May 2006
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016