NCT00292461已完成3 期
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized 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
- 64
- 试验地点
- 6
- 主要终点
- The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.
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
- None
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
Active Comparator
tablet
干预措施: Zonisamide (Drug)
lamotrigine
Active Comparator
tablet
干预措施: Lamotrigine (Drug)
结局指标
主要结局
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
时间窗: Baseline and 16 weeks
Percentage Change of Frequency = (T-B)/B\*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)\* 4 B= The monthly seizure frequence with one month prior to enrollment
次要结局
- Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period(Baseline and 16 weeks)
- Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period(Baseline and 16 weeks)
- Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.(Baseline and 16 weeks)
研究者
研究点 (6)
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