NCT01127165已完成4 期
A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy
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
- 125
- 试验地点
- 11
- 主要终点
- Percentage of Participants Who Were Assessed As Seizure Free
研究概览
简要总结
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 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 Low Dose Group
Experimental
干预措施: zonisamide low dose group (Drug)
Zonisamide High Dose group
Experimental
干预措施: zonisamide high dose group (Drug)
结局指标
主要结局
Percentage of Participants Who Were Assessed As Seizure Free
时间窗: 24 weeks
The percentage of participants who showed no seizure during the maintenance phase.
次要结局
- Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)(Baseline and 24 weeks)
- Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)(Baseline and 24 weeks)
- Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)(Baseline and 24 weeks)
研究者
研究点 (11)
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