A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Dose-Titration Study on the Efficacy and Safety of CHI-921 on Sleep Initiation and Maintenance in Subjects With Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change from baseline of PSG latency to persistent sleep
研究概览
简要总结
Insomnia is a disorder where people are having trouble sleeping and can include difficulty falling asleep, staying asleep and waking up too early, as well as having unrefreshing sleep. CHI-921 is a cannabis extract in sunflower oil produced as a treatment for insomnia. This trial is designed to evaluate the efficacy and safety of CHI-921 on people with insomnia.
详细描述
The study is designed to:
- Evaluate the patient-reported sleep latency and patient-reported wake after sleep onset after 3 weeks per treatment dose with CHI-921 compared to placebo.
- To evaluate the effects of CHI-921 compared to placebo on PSG sleep architecture.
- To evaluate the effects of CHI-921 compared to placebo on Patient Global Impression of change.
- To evaluate the daytime residual effects that may be associated with CHI-921 as compared to placebo during the double-blind treatment period using patient's morning and evening questionnaire, Clinical Global Impression of change, Insomnia Severity Index, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale as well as the Rey Auditory Verbal Learning Test and Digit Symbol Substitution psychometric tests.
- To assess the effect on sleep of abruptly discontinuing CHI-921 compared to placebo (during run-out period).
- To evaluate the clinical safety and tolerability of CHI-921 compared to placebo.
- Evaluation of the accuracy of sleep data obtained by actigraphy as compared to traditional PSG.
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
- 25 Years 至 70 Years（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
CHI-921
During the double-blind treatment period (9 weeks), subjects will take 0.5 mL of their randomized treatment (CHI-921) for 3 weeks, followed by another 3 weeks of treatment at 1.0 mL for and another 3 weeks of treatment at 2.0 mL.
干预措施: CHI-921 (Drug)
Placebo
During the double-blind treatment period (9 weeks), subjects will take 0.5 mL of their randomized treatment (placebo) for 3 weeks, followed by another 3 weeks of placebo treatment at 1.0 mL for and another 3 weeks of placebo treatment at 2.0 mL.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline of PSG latency to persistent sleep
时间窗: after 3 weeks per treatment dose with CHI-921 compared to placebo
Change from baseline of PSG wake after sleep onset (WASO)
时间窗: after 3 weeks per treatment dose with CHI-921 compared to placebo
次要结局
- Epworth Sleepiness Scale (ESS)(Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63)
- Rey Auditory Verbal Learning Test(Visit 2/Screening Night 1 and 2, Visit 3/ Night 1, Visit 4/Night 21 and 22, Visit 5/Night 42 and 43, Visit 6/Night 63)
- Digit Symbol Substitution Test(Visit 2/Screening Night 1 and 2, Visit 3/ Night 1, Visit 4/Night 21 and 22, Visit 5/Night 42 and 43, Visit 6/Night 63)
- Change from baseline of patient-reported mean sleep latency (subjective sleep latency).(after 3 weeks of treatment)
- Change from baseline on PSG sleep architecture: percentage of total sleep spent in each sleep stage (N1, N2, N3 and rapid eye movement [REM] sleep)(after 3 weeks of treatment)
- Change from baseline of patient-reported mean wake after sleep onset (subjective WASO)(after 3 weeks of treatment)
- Patient Global Impression of change (PGI-c)(Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63)
- Clinical Global Impression of change (CGI-c)(Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63)
- Insomnia Severity Index (ISI)(Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63)
- Pittsburgh Sleep Quality Index (PSQI)(Visit 2/Screening Night 1, Visit 4/Night 21, Visit 5/Night 42, Visit 6/Night 63)