A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of V117957 in Subjects With an Alcohol Use Disorder Who Are Experiencing Insomnia Associated With Alcohol Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 16
- 主要终点
- Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation, compared to placebo.
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
- Triple (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
V117957 1 mg
V117957 tablets taken orally at bedtime
干预措施: V117957 tablets (Drug)
V117957 2 mg
V117957 tablets taken orally at bedtime
干预措施: V117957 tablets (Drug)
Placebo
Placebo to match V117957 tablets taken orally at bedtime
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)
时间窗: Baseline, Nights 1 / 2, Nights 20 / 21
Wakefulness After Sleep Onset, as measured by PSG, was defined as wake time after persistent sleep (wake time during sleep plus wake time after sleep, expressed in minutes). Nights 1 / 2 is the average of the PSG measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the PSG measurements taken during nights 20 and 21 of study drug exposure.
次要结局
- Change From Baseline in Subjective Morning Sleepiness on Awakening(Baseline, Nights 1 / 2, Nights 20 / 21)
- Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)(Baseline, Night 2 (9- and 10-hours postdose), Night 21 (9- and 10-hours postdose))
- Change From Baseline in Subjective Sleep Quality (sSleep)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Change From Baseline in Subjective Total Sleep Time (sTST)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Occurrence of Rebound Insomnia During the Washout/Follow-up Period(Baseline Compared to Washout/Follow-up Period (Nights 22 / 23))
- Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST).(Baseline, Night 2, Night 21)
- Change From Baseline in Subjective Sleep Efficiency (sSE)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief(Baseline, Night 2, Night 21)
- Change From Baseline in Mean Latency to Persistent Sleep (LPS)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Change From Baseline in Mean Number of Awakenings (NAW)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Change From Baseline in Subjective Sleep Onset Latency (sSOL)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Change From Baseline in Mean Sleep Efficiency (SE)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Change From Baseline in Mean Total Sleep Time (TST)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Change From Baseline in Subjective Number of Awakenings (sNAW)(Baseline, Nights 1 / 2, Nights 20 / 21)
- Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo(Nights 1 / 2, Nights 20 / 21)