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