NCT05885646招募中不适用
Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
University Hospital, Angers3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年10月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
研究概览
简要总结
The effect of sulthiame on EEG has been studied in epilepsy syndromes of childhood with sleep activation by comparing sleep EEG obtained at baseline and after 4 weeks of treatment. The aim of the study is to know if an effect is still identifiable after 2 weeks of treatment by performing sleep EEG recordings after 2 and 4 weeks of treatment, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epilepsy syndromes of childhood with sleep activation
- •Failure of at least two anti-epileptic drugs (AED)
- •Sleep EEG performed in the last 7 days before inclusion and showing interictal epileptiform discharges (baseline EEG)
排除标准
- •Previous trial with sulthiame
- •More than 2 AED at inclusion
- •Use of corticosteroids at inclusion
- •Change in the anti-epileptic treatment in the 7 days before baseline EEG
结局指标
主要结局
Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (3)
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