A Randomized Control Trial on effectiveness of Clonazepam Versus Nitrazepam after failure of Steroids and Vigabatrin in Infantile Epileptic Spasm Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To asses the Response in participants in term of reduction in number of spasms
研究概览
简要总结
Infantile Epileptic Spasm Syndrome which is Characterised by Epileptic spasms, Developmental Delay and Hypsarrhythmia or its varient on EEG, is a difficult to treat syndrome.The infantile spasms are initially treated with Steroids(ACTH or Prednisolone) and Vigabatrin. However not all cases respond to the first line therapy .Hence second line therapy with Benzodiazepines and other drugs are used to treat these resistant cases. But there is paucity of trialsand literature on the Second line therapy more so on Benzodiazepines. Hence this study was undertaken to compare effectiveness of two commonly used Benzodiazepines Nitrazepam and Clonazepam in Infantile Epileptic Spasm Syndrome.
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 Month(s) 至 3.00 Year(s)（—）
- 性别
- All
入选标准
- •Children diagnosed with west syndrome not responding to steroids and Vigabatrin.
排除标准
- •Children in whom Benzodiazepines are contraindicated.
- •Children inncompletely treated or partially treated with First Line Drugs.
结局指标
主要结局
To asses the Response in participants in term of reduction in number of spasms
时间窗: To asses the Response in participants in term of reduction in number of spasms after 2 weeks of Starting the Drug Therapy then follow up after 1motn,3month and 6month.
次要结局
- Developmental improvement in all the developmental milestones.(At the end of 6 months of study)
研究者
Dr Vidya
INDIRA GANDHI INSTITUE OF CHILD HEALTH ,