A Multi-center, Double-blind, Randomized, Placebo-controlled, 2-way Cross-over Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 16
- 主要终点
- Change From Baseline to Week 4 in sTST
研究概览
简要总结
A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form (ICF) prior to any study-mandated procedure.
- •Male or female subjects ≥ 55 years old at the time of signing the ICF.
- •Insomnia complaints for at least 3 months prior to Visit
- •Insomnia Severity Index© (ISI©) score ≥ 13 at Visit
- •Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit
- •Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation.
排除标准
- •Woman of childbearing potential, pregnant or plans to become pregnant.
- •Planned travel across ≥ 3 time zones during study.
- •Life time history of suicidality assessed via Columbia Suicide Severity Rating Scale© (C-SSRS©).
- •Regular caffeine consumption after 4 pm.
- •Unable to refrain from smoking during the night.
- •Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or rapid eye movement (REM) sleep behavior disorder.
- •Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, central or nephrogenic diabetes insipidus, and primary/secondary polydipsia.
- •Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit
- •Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
研究组 & 干预措施
50 mg daridorexant
Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.
干预措施: Daridorexant (Drug)
Placebo
Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in sTST
时间窗: From baseline to Week 4 per treatment period.
Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization. Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).
次要结局
未报告次要终点