A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
lamotrigine 300
300 mg/day treatment
干预措施: lamotrigine, 300 mg/day (Drug)
lamotrigine 250
250 mg/day treatment
干预措施: lamotrigine, 250 mg/day (Drug)
结局指标
主要结局
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)
时间窗: 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.
次要结局
- 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))