Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
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
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Arkansas
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Hot Springs、Arkansas、美国、71913
- Central Arkansas Research
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California
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Los Angeles、California、美国、90048
- Pacific Sleep Medicine Services, Inc.
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San Diego、California、美国、92121
- Pacific Sleep Medicine Services, Inc.
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San Diego、California、美国、92123
- California Clinical Trials Medical Group, Inc.
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Florida
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Brandon、Florida、美国、33511
- PAB Clinical Research
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Miami、Florida、美国、33173
- Miami Research Associates
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Naples、Florida、美国、34110
- OmniTrials
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Pembroke Pines、Florida、美国、33026
- Broward Research Group & Sleep-Wake Disorders Center of South Florida
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Georgia
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Atlanta、Georgia、美国、30342
- Sleep Disorders Center of Georgia
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Atlanta、Georgia、美国、30342
- NeuroTrials Research, Inc.
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Kansas
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Overland Park、Kansas、美国、66212
- Vince and Associates Clinical Research
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Kentucky
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Crestview Hills、Kentucky、美国、41017
- Community Research
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Michigan
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Troy、Michigan、美国、48098
- Clinical Neurophysiology Services, P.C.
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Missouri
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Chesterfield、Missouri、美国、63017
- Sleep Disorders & Research Center
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Nevada
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Las Vegas、Nevada、美国、89104
- Clinical Research Center of Nevada
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University
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Ohio
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Cincinnati、Ohio、美国、45227
- Tri-State Sleep Disorders Center
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Health Systems
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Oklahoma
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Oklahoma City、Oklahoma、美国、73112
- Lynn Health Sciences Institute
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South Carolina
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Columbia、South Carolina、美国、29201
- Sleep Disorders Center
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Texas
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Dallas、Texas、美国、75231
- Sleep Medicine Associates P.A.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Elderly subjects (> 64 years) with a diagnosis of primary insomnia.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ABECD
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：BCADE
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：CDBEA
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：DECAB
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：EADBC
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：DCEBA
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：EDACB
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：AEBDC
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：BACED
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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实验性的：CBDAE
5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Wake Time After Sleep Onset (WASO)
大体时间：2 treatment nights
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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). |
2 treatment nights
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Total Sleep Time (TST)
大体时间：2 treatment nights
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TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)). Mean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by 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 TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included). |
2 treatment nights
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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