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| Name | Class |
|---|---|
| Purdue Pharma LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V117957 1 mg | Experimental | V117957 tablets taken orally at bedtime |
|
| V117957 2 mg | Experimental | V117957 tablets taken orally at bedtime |
|
| Placebo | Placebo Comparator | Placebo to match V117957 tablets taken orally at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V117957 tablets | Drug | V117957 tablets taken orally at bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sleep Efficiency (SE) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
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Key Inclusion Criteria include:
Male or female, 18-64 years of age with a body weight of 50-100 kg (110-220 lbs) and a body mass index (BMI) of 18-32 kg/m2.
Otherwise healthy as determined by medical evaluation that includes: medical history, physical examination, neurological exam, laboratory tests, vital signs, and cardiac monitoring.
History of moderate or severe alcohol use disorder (AUD) categorized based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria, as follows:
At least 3 weeks and not more than 6 months since last alcoholic beverage intake at the time of study screening. Any subject who completed an alcohol detoxification program must be at least 7 days from completion of the program at the time of screening.
Persistent insomnia that emerged or worsened during AUD period, or during or after alcohol cessation characterized by a study-specific sleep diary.
A female participant is eligible to participate if she is not pregnant and not breastfeeding. Both females of childbearing potential and nonsurgically sterilized males with a sexual partner of childbearing potential must be willing to use adequate and reliable contraception throughout the study.
Willing to refrain from a behavioral or other treatment program for insomnia during participation in the study.
Key Exclusion Criteria include:
Other protocol-specific inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91206 | United States | ||
| Artemis Institute for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37883189 | Derived | Whiteside GT, Kyle DJ, Kapil RP, Cipriano A, He E, Zhou M, Shet MS, Hummel M, Knappenberger T, Fukumura K, Matsuo Y, Uehira M, Hiroyama S, Takai N, Willsie SK, Harris SC. The nociceptin/orphanin FQ receptor partial agonist sunobinop promotes non-REM sleep in rodents and patients with insomnia. J Clin Invest. 2024 Jan 2;134(1):e171172. doi: 10.1172/JCI171172. |
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This was a multi-center study conducted at study sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | V117957 1 mg | V117957 tablets taken orally at bedtime V117957 tablets: V117957 tablets taken orally at bedtime |
| FG001 | V117957 2 mg | V117957 tablets taken orally at bedtime V117957 tablets: V117957 tablets taken orally at bedtime |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2019 |
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| Placebo |
| Drug |
Tablets to match V117957 |
|
| Change From Baseline in Mean Latency to Persistent Sleep (LPS) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Mean Total Sleep Time (TST) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Mean Number of Awakenings (NAW) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Subjective Sleep Quality (sSleep) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Subjective Total Sleep Time (sTST) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Subjective Sleep Onset Latency (sSOL) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Subjective Sleep Efficiency (sSE) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Subjective Number of Awakenings (sNAW) | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Change From Baseline in Subjective Morning Sleepiness on Awakening | 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. | Baseline, Nights 1 / 2, Nights 20 / 21 |
| Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | 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. | Nights 1 / 2, Nights 20 / 21 |
| Occurrence of Rebound Insomnia During the Washout/Follow-up Period | 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). | Baseline Compared to Washout/Follow-up Period (Nights 22 / 23) |
| Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | The DSST explores attention and psychomotor speed by measuring total correct responses. The maximum score is 165. Higher scores represent better outcome/improvement. | Baseline, Night 2, Night 21 |
| Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | The KSS is a 9-point Likert scale (range: 1 = "extremely alert" to 9 = "very sleepy") that measures level of sleepiness. | Baseline, Night 2 (9- and 10-hours postdose), Night 21 (9- and 10-hours postdose) |
| Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | 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. | Baseline, Night 2, Night 21 |
| Riverside |
| California |
| 92503 |
| United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| CITrials | Santa Ana | California | 92705 | United States |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | United States |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Research Centers of America, LLC | Miami | Florida | 33157 | United States |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | United States |
| NeuroTrials Research Inc | Atlanta | Georgia | 30328 | United States |
| Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| Sleep Disorders Centers of the Mid Atlantic | Glen Burnie | Maryland | 21061 | United States |
| Wake Research - Clinical Research Center of Nevada, LLC | Las Vegas | Nevada | 89104 | United States |
| SPRI Clinical Trials | Brooklyn | New York | 11235 | United States |
| Clinilabs Drug Development Corporation | New York | New York | 10019 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Advanced Medical Trials | Georgetown | Texas | 78628 | United States |
| FG002 | Placebo | Placebo to match V117957 tablets taken orally at bedtime Placebo: Tablets to match V117957 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V117957 1 mg | V117957 tablets taken orally at bedtime V117957 tablets: V117957 tablets taken orally at bedtime |
| BG001 | V117957 2 mg | V117957 tablets taken orally at bedtime V117957 tablets: V117957 tablets taken orally at bedtime |
| BG002 | Placebo | Placebo to match V117957 tablets taken orally at bedtime Placebo: Tablets to match V117957 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Mean Sleep Efficiency (SE) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Percent | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Mean Total Sleep Time (TST) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Mean Number of Awakenings (NAW) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Number of Awakenings | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Subjective Sleep Quality (sSleep) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Subjective Total Sleep Time (sTST) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | 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. | \Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Subjective Sleep Efficiency (sSE) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Percent | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Subjective Number of Awakenings (sNAW) | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Number of Awakenings | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Change From Baseline in Subjective Morning Sleepiness on Awakening | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Count of Participants | Participants | Nights 1 / 2, Nights 20 / 21 |
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| Secondary | Occurrence of Rebound Insomnia During the Washout/Follow-up Period | 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). | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Minutes | Baseline Compared to Washout/Follow-up Period (Nights 22 / 23) |
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| Secondary | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | The DSST explores attention and psychomotor speed by measuring total correct responses. The maximum score is 165. Higher scores represent better outcome/improvement. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | Correct Responses | Baseline, Night 2, Night 21 |
|
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| Secondary | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | The KSS is a 9-point Likert scale (range: 1 = "extremely alert" to 9 = "very sleepy") that measures level of sleepiness. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Night 2 (9- and 10-hours postdose), Night 21 (9- and 10-hours postdose) |
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| Secondary | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | 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. | Full analysis population: The group of subjects who were randomly assigned to 1 of the 3 treatment groups, received study drug, and had at least 1 valid postdose efficacy measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Night 2, Night 21 |
|
Adverse events (AEs) were reported from the start of study participation up to 3 weeks. All-cause mortality and serious adverse events were reported from the start of study participation up to 30 days after last study drug dose (approximately 7 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V117957 1 mg | V117957 tablets taken orally at bedtime V117957 tablets: V117957 tablets taken orally at bedtime | 0 | 38 | 0 | 38 | 5 | 38 |
| EG001 | V117957 2 mg | V117957 tablets taken orally at bedtime V117957 tablets: V117957 tablets taken orally at bedtime | 0 | 38 | 0 | 38 | 14 | 38 |
| EG002 | Placebo | Placebo to match V117957 tablets taken orally at bedtime Placebo: Tablets to match V117957 | 0 | 38 | 0 | 38 | 7 | 38 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Imbrium Therapeutics | 1-888-726-7535 | Purduemedinfo@pharma.com |
| Jul 26, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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