NCT00380003已完成2 期
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients
Evotec Neurosciences GmbH10 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 10
- 主要终点
- Total Sleep Time
研究概览
简要总结
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have a diagnosis of primary insomnia
- •over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- •must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
- •must be willing and able to complete a sleep diary and questionnaires
排除标准
- •must not have a clinically significant or unstable medical condition that may interfere with sleep
- •must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
- •must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
- •must not intentionally nap 3 (or more) times per week
- •must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)
结局指标
主要结局
Total Sleep Time
Wake after sleep onset
次要结局
- Residual sedation measures
- REM latency
- Patient reported sleep variables
- Latency to persistent sleep
- Total wake time
- Minutes of stages 1-4 and REM sleep
- Number of awakenings
- Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments.
研究者
研究点 (10)
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