CTRI/2024/10/075501尚未招募3 期
Comparison of efficacy and tolerability of levetiracetam and valproate for newly diagnosed generalised and unclassifiable epilepsy in adolescent girls aged 10-18 years: a randomized controlled trial
Dr Suthiraj S1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2024年10月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Number of participants with seizure freedom
研究概览
简要总结
In this RCT we want to compare the efficacy and tolerability of two commonly used anti-seizure medications; valproate and levetiracetam in adolecsent girls with generalized and unclassifiable epilepsy aged 10-18 years. Both drugs will be administered to participants for 24 weeks and we will compare the number of patienst with seizure freedom and adverse effects 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
- 10.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Newly diagnosed case of generalized or unclassifiable epilepsy 2.History of at least one convulsive seizure within previous one month.
排除标准
- •Parents not providing informed consent
- •Adolescent suffering fromc hronic hepatic or renal disease
- •Only acute symptomatic seizures.
结局指标
主要结局
Number of participants with seizure freedom
时间窗: At 24 weeks
次要结局
- Number of participants with any adverse effect due to study medication(24 weeks)
研究者
Dr Suthiraj S
AIIMS, Rishikesh
研究点 (1)
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