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临床试验/CTRI/2024/05/067011
CTRI/2024/05/067011尚未招募2 期

Comparison of efficacy of valproate and oxcarbazepine in children with self-limited epilepsy with centrotemporal spikes: a randomized control trial VO-SELECT trial

Aditi Gupta1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年5月15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
114
试验地点
1
主要终点
Proportion of participants who remain seizure free in each group

研究概览

简要总结

This RCT will compare two commonly used anti-epileptic drugs valproate and oxcarbazepine in children with self-limited epilepsy with centro-temporal spikes, aged 3-14 years. This is a very common type of epilepsy in children. In this RCT, we will randomize 114 eligible cases of newly diagnosed self limited epilepsy with centro-temporal spikes to either oxcarbazepine or valproate group. While oxcarbazepine group will receive the drug at 15 mg/kg/day in two divided doses daily for 12 weeks, the participants in valproate group will receive the drug at 20 mg/kg/day in two divided doses for 12 weeks. We will compare the proportion of participants who remain seizure free at 12 weeks in both groups and also number of participants with any adverse effect 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
3.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed cases of self-limited epilepsy with centrotemporal spikes.

排除标准

  • History of allergy to either study medication.

结局指标

主要结局

Proportion of participants who remain seizure free in each group

时间窗: At 12 weeks

次要结局

  • Number of participants with adverse effects related to study medication(At 12 weeks)

研究者

发起方
Aditi Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aditi Gupta

AIIMS, Rishikesh

研究点 (1)

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