CTRI/2025/11/097310尚未招募2 期
Comparison of Efficacy of Levetiracetam and Brivaracetam in Children with Epilepsy with Myoclonic-Atonic Seizures: a randomized controlled trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of participants with at least 50% reduction in average weekly seizure frequency
研究概览
简要总结
This will be an open-label randomized controlled trial, which will compare the efficacy of two anti-seizure medications (brivaracetam and levetiracetam) in children with epilepsy with myoclonic atonic seizures aged 2-8 years. Both medications will be administered daily for 8 weeks. We will compare the proportion of participants with at least a 50% reduction in average weekly seizure frequency in both groups.
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 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinical diagnosis of Epilepsy with Myoclonic Atonic Seizures, characterized by myoclonic-atonic seizures with supportive EEG features.
- •2.Failure to respond adequately to at least one first-line anti-seizure medication (sodium valproate) 3.Minimum baseline seizure frequency of at least 1 myoclonic-atonic seizure per day over the previous 4 weeks.
排除标准
- •Prior exposure to either levetiracetam or brivaracetam.
- •Significant hepatic or renal impairment.
结局指标
主要结局
Proportion of participants with at least 50% reduction in average weekly seizure frequency
时间窗: At 8 weeks
次要结局
- Number of clinical seizure-free days(At 8 weeks)
研究者
Dr Prateek Kumar Panda
All India Institute of Medical Sciences, Rishikesh
研究点 (1)
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