Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 709
- 试验地点
- 90
- 主要终点
- Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
研究概览
简要总结
A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult subjects (18-64 years) with a diagnosis of primary insomnia.
排除标准
- •History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) axis I disorder other than primary insomnia.
- •Sleep apnea, or restless legs syndrome.
- •Daytime napping of more than 1 hour per day.
- •Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
- •Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
研究组 & 干预措施
1
almorexant 200 mg
干预措施: almorexant (Drug)
2
almorexant 100 mg
干预措施: almorexant (Drug)
3
Placebo
干预措施: Placebo (Drug)
4
zolpidem 10 mg
干预措施: zolpidem (Drug)
结局指标
主要结局
Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)
时间窗: From baseline to Day 1&2
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16
Change From Baseline to Day 15&16 in WASO
时间窗: From baseline to Day 15&16
WASO was defined as the time spent in epochs scored as wake after onset of persistent sleep as determined by polysomnography (PSG) until lights on. For WASO assessed at the study center, the mean of the 2 PSG nights at each of Visits 3 and 4 was used for Day 1\&2 and Day 15\&16
Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)
时间窗: From baseline to Week 1&2
sWASO was the self-reported time spent awake after sleep onset as reported in the sleep diary. For sWASO assessed at home, the mean of all available data collected between Visits 3 and 4 (i.e., after the second morning of Visit 3 and before the first evening of Visit 4) was used for Week 1\&2
次要结局
- Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)(From baseline to Day 1&2)
- Change From Baseline to Day 15&16 in LPS(From baseline to Day 15&16)
- Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)(From baseline to Week 1&2)