NCT06701396招募中3 期
A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Latency to Persistent Sleep, as measured by polysomnography.
研究概览
简要总结
This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Ability and acceptance to provide written informed consent.
- •A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
- •Carrier of CRY1Δ11 variant.
- •Men or women between 18 - 75 years, inclusive.
- •Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m^2.
排除标准
- •Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
- •Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
- •A positive test for substances of abuse.
- •Current tobacco user.
研究组 & 干预措施
Tasimelteon
Experimental
干预措施: Tasimelteon (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Latency to Persistent Sleep, as measured by polysomnography.
时间窗: Two Nights
次要结局
未报告次要终点
研究者
研究点 (1)
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