Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
- Conditions
- Insomnia
- Interventions
- Drug: V117957 tabletsDrug: Placebo
- Registration Number
- NCT04035200
- Lead Sponsor
- Imbrium Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V117957 1 mg V117957 tablets V117957 tablets taken orally at bedtime Placebo Placebo Placebo to match V117957 tablets taken orally at bedtime V117957 2 mg V117957 tablets V117957 tablets taken orally at bedtime
- Primary Outcome Measures
Name Time Method Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Subjective Morning Sleepiness on Awakening Baseline, Nights 1 / 2, Nights 20 / 21 Self-reported sleep outcome measured by subject diary data. Individual scores have a range of 1 to 5, with 1 being equal to "Not at All Rested" and 5 being equal to "Very Well Rested." Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
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) The KSS is a 9-point Likert scale (range: 1 = "extremely alert" to 9 = "very sleepy") that measures level of sleepiness.
Change From Baseline in Subjective Sleep Quality (sSleep) Baseline, Nights 1 / 2, Nights 20 / 21 Self-reported sleep outcome measured by subject diary data. Scores have a range of 1 to 5, with 1 being equal to "Very Poor" and 5 being equal to "'Very Good."
Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.Change From Baseline in Subjective Total Sleep Time (sTST) Baseline, Nights 1 / 2, Nights 20 / 21 Self-reported sleep outcome measured by subject diary data. Total sleep time is reported in minutes.
Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) Baseline, Nights 1 / 2, Nights 20 / 21 Self-reported sleep outcome measured by subject diary data. WASO is 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 measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.Occurrence of Rebound Insomnia During the Washout/Follow-up Period Baseline Compared to Washout/Follow-up Period (Nights 22 / 23) Rebound insomnia is defined as a worsening of sleep compared with pretreatment. The comparison is based on the Wakefulness After Sleep Onset (WASO) measured by PSG of the Washout/Follow-up Period versus Baseline. If the LS means for WASO for the Washout/Follow-up Period is lower than Baseline, then no rebound insomnia was suggested. Nights 22 / 23 is the average of the measurements taken during nights 22 and 23 (Washout Period).
Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). Baseline, Night 2, Night 21 The DSST explores attention and psychomotor speed by measuring total correct responses. The maximum score is 165. Higher scores represent better outcome/improvement.
Change From Baseline in Subjective Sleep Efficiency (sSE) Baseline, Nights 1 / 2, Nights 20 / 21 Self-reported sleep outcome measured by subject diary data. Sleep efficiency (SE) is calculated by dividing the time asleep by the total time in bed multiplied by 100 (SE is reported as percent).
Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief Baseline, Night 2, Night 21 The POMS-Brief contains 30 questions that assess mood states. Scores for each question range 0 = not at all to 4 = extremely. Total mood disturbance assessment is the total of the subject's subscales scores on anger/hostility, confusion/bewilderment, depression/dejection, fatigue/inertia, tension/anxiety, and vigor/activity. Total scores range from 0-120 and a higher total score indicates more mood disturbance.
Change From Baseline in Mean Latency to Persistent Sleep (LPS) Baseline, Nights 1 / 2, Nights 20 / 21 Latency to onset of persistent sleep (LPS), as measured by PSG, is defined as time from lights-off to the first of 20 consecutive periods of non-wake sleep stages. Latency to persistent sleep is reported 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.Change From Baseline in Mean Number of Awakenings (NAW) Baseline, Nights 1 / 2, Nights 20 / 21 Sleep component as measured by PSG. Number of awakenings is determined from persistent sleep to lights-on. An awakening is defined as a PSG recording of at least 2 consecutive wake periods.
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.Change From Baseline in Subjective Sleep Onset Latency (sSOL) Baseline, Nights 1 / 2, Nights 20 / 21 Self-reported sleep outcome measured by subject diary data. Sleep onset latency (SOL) is the time it takes to fall asleep after turning the lights out.
Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.Change From Baseline in Mean Sleep Efficiency (SE) Baseline, Nights 1 / 2, Nights 20 / 21 Sleep efficiency, as measured by PSG, is defined as Total Sleep Time (TST), divided by total recording time, multiplied by 100.
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.Change From Baseline in Mean Total Sleep Time (TST) Baseline, Nights 1 / 2, Nights 20 / 21 Total sleep time, as measured by PSG, is the duration of rapid eye movement (REM) plus NREM (stages N1 + N2 + N3) during time in bed.
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.Change From Baseline in Subjective Number of Awakenings (sNAW) Baseline, Nights 1 / 2, Nights 20 / 21 Self-reported sleep outcome measured by subject diary data. The subject recorded the number of awakenings in the diary.
Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo Nights 1 / 2, Nights 20 / 21 The proportion of responders is based on subjects meeting or exceeding WASO (wakefulness after sleep onset) 15 minute threshold as derived from polysomnography (PSG).
Nights 1 / 2 is the average of the measurements taken during the first two nights of study drug exposure. Nights 20 / 21 is the average of the measurements taken during nights 20 and 21 of study drug exposure.
Trial Locations
- Locations (16)
SPRI Clinical Trials
🇺🇸Brooklyn, New York, United States
Investigational Site
🇺🇸Chevy Chase, Maryland, United States
Innovative Clinical Research, Inc.
🇺🇸Miami Lakes, Florida, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
SDS Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
Wake Research - Clinical Research Center of Nevada, LLC
🇺🇸Las Vegas, Nevada, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Research Centers of America, LLC
🇺🇸Miami, Florida, United States
California Clinical Trials Medical Group
🇺🇸Glendale, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
CITrials
🇺🇸Santa Ana, California, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Sleep Disorders Centers of the Mid Atlantic
🇺🇸Glen Burnie, Maryland, United States
Clinilabs Drug Development Corporation
🇺🇸New York, New York, United States
Advanced Medical Trials
🇺🇸Georgetown, Texas, United States