NCT01401413已完成4 期
A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder
Sleep Medicine Centers of WNY1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in polysomnographic scores
研究概览
简要总结
The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.
详细描述
This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for RBD as determined by screening PSG's
- •steady bed partner for completion of RBD questionnaire
排除标准
- •Hepatic impairment
- •RBD associated with narcolepsy
- •use of fluvoxamine, rifampin, fluconazole or ketoconazole
- •current alcohol or drug abuse
研究组 & 干预措施
1
Placebo Comparator
placebo control nightly
干预措施: placebo (Drug)
2
Active Comparator
8 mg ramelteon nightly
干预措施: ramelteon (Drug)
结局指标
主要结局
Change in polysomnographic scores
时间窗: 30 days
次要结局
- change in RBD symptom questionnaire and sleep diary(30 days)
研究者
研究点 (1)
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