NCT00245713已完成4 期
9-11 Week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Determine Effects of Adjunctive Levetiracetam on Sleep Architecture of Adults With Partial Onset Epilepsy Receiving a First Generation Anti-epileptic Drug.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 40
- 主要终点
- Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.
研究概览
简要总结
Effect of adjunctive levetiracetam on polysomnography in adults with partial-onset epilepsy receiving a classical antiepileptic drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have partial onset epilepsy and have been taking carbamazepine or phenytoin at a stable dose for a period of 4 weeks prior to the selection visit
- •Subjects must have controlled partial onset seizures which can potentially benefit from adjunctive treatment
排除标准
- •Subjects dosing with LEV two weeks prior to the selection visit
- •Subjects using more than one AED
- •Subjects with specific and non-specific sleep disorders
结局指标
主要结局
Changes from Baseline to visit 7 in percent REM, percent slow wave sleep (stages 3 and 4), and sleep efficiency (which is total sleep time ÷ time in bed defined as lights out), with particular focus on sleep efficiency.
次要结局
- Secondary endpoints are based on the changes from Baseline to visit 7
研究者
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