NCT00643136已完成3 期
Pregabalin BID Add-on Trial: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Single-Center Sleep EEG Study in Patients With Partial Seizures and Sleep Disturbance Part B: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Pregabalin Add-on Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population
研究概览
简要总结
The purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial epileptic seizures
- •Not taking more than 1 background antiepileptic drug at study entry
- •Disturbed sleep
排除标准
- •More than 1 secondarily generalized tonic/clonic seizure per week on average over the previous 3 months
- •Medical, psychological, or social conditions that could interfere with normal sleep
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Pregabalin
Experimental
干预措施: Pregabalin (Drug)
结局指标
主要结局
Change from baseline in polysomnographic (PSG) sleep efficiency in the efficacy evaluable population
时间窗: Endpoint
次要结局
- Change from baseline in total sleep time(Endpoint)
- Change from baseline in sleep onset latency(Endpoint)
- Change from baseline in wake after sleep onset(Endpoint)
- Change from baseline in percent sleep spent in stages 3 and 4(Endpoint)
- Change from baseline in percent sleep spent in REM stage(Endpoint)
- Change from baseline in night sleep quality based on Groningen Sleep Questionnaire (GSQ)(Endpoint)
- Change from baseline in 4-week sleep quality (Medical Outcomes Study [MOS] Sleep Scale)(Endpoint)
- Adverse events and laboratory value changes(Endpoint)
研究者
研究点 (1)
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