EUCTR2017-004643-20-HU进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
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) for any indication is allowed, only, if CBT 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.
研究者
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