NCT01127256已完成4 期
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- The Percentage of Participants With Seizure Free Rate
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
详细描述
To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.
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
- 15 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
1
Experimental
干预措施: zonisamide (Drug)
2
Active Comparator
干预措施: carbamazepine (Drug)
结局指标
主要结局
The Percentage of Participants With Seizure Free Rate
时间窗: 24 weeks
The percentage of participants who had no seizure during the trial.
次要结局
- The Percentage of Participants With Retention Rate(24 weeks)
- Quality of Life in Epilepsy (QoL-QOLIE31)(24 weeks)
研究者
研究点 (12)
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