CTRI/2025/01/078958尚未招募2 期
Comparison of efficacy of adjunctive oral levetiracetam and topiramate for focal onset seizures in children aged 2-18 years: a randomized controlled trial
Dr Ashish Jha1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年1月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Proportion of participants with seizure freedom
研究概览
简要总结
This will be an open-labeled two-arm parallel design randomized controlled trial, which will compare the efficacy of oral levetiracetam and topiramate in children with focal epilepsy aged 2-18 years. At the end of 12 weeks, we will compare the number of participants with seizure freedom and the number of participants requiring additional anti-seizure medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with focal epilepsy Seizures uncontrolled on one anti-seizure medication.
排除标准
- •Children already receiving oral topiramate or levetiracetam Coexistent generalized seizures.
结局指标
主要结局
Proportion of participants with seizure freedom
时间窗: 12 weeks
次要结局
- Number of participants requiring additional ASM(12 weeks)
研究者
Dr Ashish Jha
All India Institute of Medical Sciences, Rishikesh
研究点 (1)
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