NCT02231008已完成2 期
A Double-blind, Randomized, Two-period Crossover Study Evaluating the Effects of Tasimelteon vs. Placebo on Sleep Disturbances of Individuals With Smith-Magenis Syndrome (SMS)
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
- 49
- 主要终点
- To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters
研究概览
简要总结
The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed clinical diagnosis of SMS
- •Informed consent from the patient or the legal guardian
- •Male or female between the ages of 3- 65 years of age
- •Recent history of sleep disturbances
- •Have an appointed care-giver complete the required outpatient assessments
- •Willing and able to comply with study requirements and restrictions
排除标准
- •Unable to dose daily with medication
- •Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening
- •Any other sound medical reason as determined by the clinical investigator
研究组 & 干预措施
Tasimelteon
Experimental
Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage
干预措施: tasimelteon (Drug)
Placebo
Placebo Comparator
Placebo comparator
干预措施: placebo (Drug)
结局指标
主要结局
To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters
时间窗: 9 Weeks
次要结局
- Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).(up to 137 weeks)
研究者
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