NCT00327717已完成3 期
A Multicenter, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase
研究概览
简要总结
The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).
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
- 16 Years 至 70 Years（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
Zonisamide 100 mg tablet
Experimental
干预措施: Zonisamide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase
时间窗: Baseline and 16 weeks
The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.
次要结局
- The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency(Baseline and 16 weeks)
- The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency(Baseline and 16 weeks)
- The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)(Baseline and 16 weeks)
- Responder Rate(Baseline and 16 weeks)
- Mean Number of Seizure Free Days(12 weeks)
- Mean Percentage of Change in Seizure Free Days(16 weeks)
- Mean Time to First Seizure (Days)(16 weeks)
- Percentage of Seizure-free Participants During Fixed-dose Phase(16 weeks)
- Drop - Out Rate(16 weeks)
研究者
研究点 (8)
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