Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 20
- 主要终点
- Mean Wake Time After Sleep Onset (WASO)
研究概览
简要总结
A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly subjects (> 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 IV (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
ABECD
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 oral capsules at 25 and 100 mg and matching placebo (Drug)
BCADE
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
CDBEA
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
DECAB
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
EADBC
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
DCEBA
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
EDACB
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
AEBDC
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
BACED
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
CBDAE
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
干预措施: ACT-078573 and matching placebo (Drug)
结局指标
主要结局
Mean Wake Time After Sleep Onset (WASO)
时间窗: 2 treatment nights
WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake. Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).
次要结局
- Mean Total Sleep Time (TST)(2 treatment nights)