A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 1,006
- 试验地点
- 95
- 主要终点
- Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30
研究概览
简要总结
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.
详细描述
The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for 30 nights in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. Approximately 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Zolpidem tartrate
Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
干预措施: Zolpidem tartrate (Drug)
Lemborexant 5 milligrams (mg)
Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
干预措施: Lemborexant (Drug)
Lemborexant 5 milligrams (mg)
Participants will receive one lemborexant 5 mg tablet and one zolpidem-matched placebo tablet each night
干预措施: Zolpidem-matched placebo (Drug)
Lemborexant 10 mg
Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
干预措施: Lemborexant (Drug)
Lemborexant 10 mg
Participants will receive one lemborexant 10 mg tablet and one zolpidem-matched placebo tablet each night
干预措施: Zolpidem-matched placebo (Drug)
Zolpidem tartrate
Participants will receive one zolpidem 6.25 mg tablet and one lemborexant-matched placebo tablet each night
干预措施: Lemborexant-matched placebo (Drug)
Placebo
Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
干预措施: Lemborexant-matched placebo (Drug)
Placebo
Participants will receive one zolpidem-matched placebo tablet and one lemborexant-matched placebo tablet each night
干预措施: Zolpidem-matched placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30
时间窗: Baseline, Days 29/30
LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported.
次要结局
- Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30(Baseline, Days 29/30)
- Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30(Baseline, Days 29/30)
- Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30(Baseline, Days 29/30)