NCT03291041已完成2 期
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted
研究概览
简要总结
A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and acceptance to provide written consent
- •Men or women between 18-75 years
- •Body Mass Index of ≥ 18 and ≤ 30 kg/m2
排除标准
- •History (within the 12 months prior to screening) of psychiatric disorders
- •Major surgery, trauma, illness or immobile for 3 or more days within the past month
- •Pregnancy or recent pregnancy (within 6 weeks)
- •A positive test for drugs of abuse at the screening visit
- •Any other sound medical reason as determined by the clinical investigator
研究组 & 干预措施
tasimelteon
Experimental
tasimelteon, administered as oral capsule(s)
干预措施: Tasimelteon (Drug)
Placebo
Placebo Comparator
Placebo, administered as oral capsule(s)
干预措施: Placebo (Drug)
结局指标
主要结局
Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted
时间窗: 4 days
Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted.
次要结局
- Subjective Sleep Latency Night 3(1 Day)
- Patient Global Impression of Severity (PGI-S) Day 4(1 Day)
- Subjective Sleep Quality Night 3(1 Day)
- Subjective Wake After Sleep Onset Night 3(1 Day)
- Karolinska Sleepiness Scale Day 4(1 Day)
- Subjective Total Sleep Time on Night 3(1 Day)
- Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights)(3 Days)
研究者
研究点 (1)
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