Comparison of Efficacy of Levetiracetam and Brivaracetam in Children with Epilepsy with Myoclonic-Atonic Seizures: a randomized controlled trial

MSN Laboratories Pvt Ltd1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年12月10日最近更新: 2025年11月12日

试验速览

阶段: 2 期
状态: 尚未招募
发起方: MSN Laboratories Pvt Ltd
入组人数: 40
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

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.

研究者

发起方

MSN Laboratories Pvt Ltd

申办方类型

Pharmaceutical industry-Indian

责任方

Principal Investigator

主要研究者

Dr Prateek Kumar Panda

All India Institute of Medical Sciences, Rishikesh

研究点 (1)

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