A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period Adaptive Crossover Polysomnography Study to Evaluate Safety and Efficacy of MK-4305 in Patients With Primary Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 254
- 主要终点
- LS Mean Sleep Efficiency (SE) During Periods 1 and 2
研究概览
简要总结
A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment
- •Must be willing to stay overnight at a sleep laboratory
- •Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
- •Regular bedtime is between 9 PM and 12 AM (midnight)
排除标准
- •Breast feeding, pregnant or planning to become pregnant during the study
- •Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
- •Currently participating or have participated in a study with an investigational compound or device within the last 30 days
- •Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study
- •Has done shift work within the past 2 weeks
- •Has donated blood products within the last 8 weeks
- •Has difficulty sleeping due to a medical condition
研究组 & 干预措施
Suvorexant 10 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Suvorexant 10 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
Placebo → Suvorexant 10 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Placebo → Suvorexant 10 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
Suvorexant 20 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Suvorexant 20 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
Placebo → Suvorexant 20 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Placebo → Suvorexant 20 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
Suvorexant 40 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Suvorexant 40 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
Placebo → Suvorexant 40 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Placebo → Suvorexant 40 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
Suvorexant 80 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Suvorexant 80 mg → Placebo
After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
Placebo → Suvorexant 80 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Suvorexant (Drug)
Placebo → Suvorexant 80 mg
After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.
干预措施: Dose-matched Placebo to Suvorexant (Drug)
结局指标
主要结局
LS Mean Sleep Efficiency (SE) During Periods 1 and 2
时间窗: Night 1 and end of Week 4
SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography \[PSG\] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100
次要结局
- LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2(Night 1 and end of Week 4)
- LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2(Night 1 and end of Week 4)