A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
Brief Summary
This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
lamotrigine 300
300 mg/day treatment
Intervention: lamotrigine, 300 mg/day (Drug)
lamotrigine 250
250 mg/day treatment
Intervention: lamotrigine, 250 mg/day (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase(The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23))
- 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)(From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23))
- Time to Discontinuation in the Treatment Phase(From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23))
- Percentage of Participants Meeting Escape Criteria in the Treatment Phase(Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23))
- Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)(Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23))
- Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase(Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase)
- 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)(Baseline and entire Continuation phase (24 Weeks))