A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 583
- 主要终点
- Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase
研究概览
简要总结
This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.
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
- 18 Years 至 75 Years（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
Zonisamide
干预措施: Zonisamide (Drug)
Carbamazepine
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase
时间窗: Week 31 through Week 109
A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
次要结局
- Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1(Baseline and Maintenance Period Visit 1 (Week 31 to Week 83))
- Time to 12-months Seizure Freedom(Week 5 through Week 83)
- Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1(Baseline and Maintenance Period Visit 1 (Week 31 to Week 83))
- Analysis of Time to Drop Out Due to Lack of Efficacy(Week 1 through Week 109)
- Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1(Baseline and Maintenance Period Visit 1 (Week 31 to Week 83))
- Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1(Baseline and Maintenance Period Visit 1 (Week 31 to Week 83))
- Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1(Week 31 through Week 83)
- Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period(Week 5 through Week 109)
- Analysis of Time to Drop Out Due to an Adverse Event (AE)(Week 1 through Week 109)
- Time to 6-months Seizure Freedom(Week 5 through Week 83)