NCT04652882进行中（未招募）3 期
A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Participants With Delayed Sleep-Wake Phase Disorder (DSWPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 18
- 主要终点
- Change in Sleep Onset over the treatment period, as measured by sleep diary.
研究概览
简要总结
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.
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
- 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).
- •Men or women between 18 - 75 years, inclusive.
- •Body Mass Index (BMI) of ≥ 18 and ≤ 35 kg/m^2.
排除标准
- •Exacerbation of an existing psychiatric condition that requires change in treatment or intervention in the past 3 months.
- •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
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Tasimelteon
Experimental
干预措施: Tasimelteon (Drug)
结局指标
主要结局
Change in Sleep Onset over the treatment period, as measured by sleep diary.
时间窗: 28 days
次要结局
- Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary.(28 days)
- Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).(28 days)
- Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy.(28 days)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
4 期
Comparison of the Efficacy and Tolerability of the Addition of AVANDIA to Submaximal Doses of MetforminDiabetes Mellitus, Type 2NCT00501020GlaxoSmithKline750
终止
3 期
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder (MDD)NCT01111565Otsuka Pharmaceutical Development & Commercialization, Inc.137
终止
3 期
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder (MDD)NCT01111539Otsuka Pharmaceutical Development & Commercialization, Inc.211
终止
3 期
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)Major Depressive Disorder (MDD)NCT01111552Otsuka Pharmaceutical Development & Commercialization, Inc.237
已完成
不适用
A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral EnhancementSubjects Desiring Lip AugmentationNCT01998581Allergan225