NCT07028697已完成3 期
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Nxera Pharma Korea Co., Ltd.17 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年12月4日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 17
- 主要终点
- Subjective total sleep time(sTST)
研究概览
简要总结
The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 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 ≥ 19 years;
- •Insomnia disorder according to DSM-5 criteria;
- •The predominant complaint is dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
- •Difficulty initiating sleep.
- •Difficulty maintaining sleep (characterized by frequent awakenings or problems returning to sleep after awakenings).
- •Early-morning awakening with inability to return to sleep.
- •Insomnia Severity Index score ≥ 15;
- •Insufficient sleep quantity as collected subjectively in the sleep diary A. ≥ 30 min to fall asleep, and B. Wake time during sleep ≥ 30 min, and C. Subjective Total Sleep Time (sTST) ≤ 6.5 h
排除标准
- •Body mass index (BMI) ≥ 40.0 kg/m2
- •Documented medical history and/or comorbidity of sleep-related breathing disorder
- •History of and/or concurrent sleep apnea or suspected sleep apnea
- •Korean-Mini Mental State Examination-2 (K-MMSE-2) score < 25 in subjects ≥ 50 years;
- •For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period
- •Initiation of the cognitive behavior therapy (CBT) for treatment of insomnia disorder within 4 weeks prior to the Screening visit (Visit 1) or planned CBT during the study
- •A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C)
- •Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.
研究组 & 干预措施
Daridorexant
Experimental
干预措施: Daridorexant (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Subjective total sleep time(sTST)
时间窗: Week 4
Change from baseline to week 4 in subjective total sleep time (sTST) measured by eDairy
次要结局
- Subjective latency to sleep onset (sLSO)(Week 4)
- Subjective wake after sleep onset (WASO)(Week 4)
研究者
研究点 (17)
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