Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 924
- 试验地点
- 85
- 主要终点
- Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
研究概览
简要总结
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure;
- •Male or female aged ≥ 18 years;
- •Insomnia disorder according to DSM-5 criteria;
- •Insomnia Severity Index score ≥ 15;
- •Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;
- •Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.
排除标准
- •Body mass index below 18.5 or above 40.0 kg/m2;
- •Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;
- •Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
- •Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
- •Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
- •Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;
- •For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
- •History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
研究组 & 干预措施
Daridorexant 10 mg
干预措施: Daridorexant (Drug)
Daridorexant 25 mg
干预措施: Daridorexant (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
时间窗: From baseline to Month 1 (i.e. for up to 1 month)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
时间窗: From baseline to Month 1 (i.e. for up to 1 month)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
时间窗: From baseline to Month 3 (i.e. for up to 3 months)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
时间窗: From baseline to Month 3 (i.e. for up to 3 months)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
次要结局
- Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)(From baseline to Month 1 (i.e. for up to 1 month))
- Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score(From baseline to Month 3 (i.e. for up to 3 months))
- Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)(From baseline to Month 3 (i.e. for up to 3 months))
- Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score(From baseline to Month 1 (i.e. for up to 1 month))