Insomnia
Conditions
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.
Interventions
DRUGV117957 tablets
V117957 tablets taken orally at bedtime
DRUGPlacebo
Tablets to match V117957
Sponsors
Purdue Pharma LP
Imbrium Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
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: * Moderate as defined by presence of 4-5 of the 11 criteria * Severe as defined by the presence of ≥ 6 of the 11 criteria. * 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: * Current diagnosis of a sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure (CPAP) treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder or narcolepsy. * An apnea-hypopnea index (AHI) score of \>10 or a periodic limb movement arousal index (PLMAI) score of \> 15 recorded during the screening period PSG. * Documented history of insomnia prior to onset of the alcohol use disorder (AUD), which did not worsen during the AUD period or during or after alcohol cessation. * Comorbid conditions which interfere with normal sleep pattern or the evaluation of next day residual effects. * Any lifetime history of suicidal ideation or behavior. * History of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion (including any surgical interventions for weight loss). * Any history of seizures (except related to alcohol withdrawal) or head trauma with sequelae. * Known history of testing positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV). * History of diagnosed, active liver disease or elevated liver enzymes/bilirubin. * History of kidney stones or renal insufficiency or abnormal kidney function at screening. * Uncontrolled hypertension (\> 140 mm Hg systolic / 90 mm Hg diastolic). * Use of any medication that affects sleep and/or wake function during the week before starting the screening period. * Subjects currently undergoing treatment of other addictions in addition to alcohol. * Excessive caffeine consumption. * Positive urine drug screen for prohibited substances, except for cannabis on a case-by-case basis. * History of drug use disorder over the past year, other than alcohol/nicotine/caffeine/cannabis. * Plans to travel across more than 3 time zones in the 2 weeks before screening, or during study participation. * Night or rotating shift worker. * Any history and/or current evidence of other medical (eg, cardiac, respiratory, gastrointestinal, renal, malignancy other than basal cell carcinoma), neurological, or psychiatric conditions that, in the opinion of the investigator, could affect the subject's safety or interfere with the study. Other protocol-specific inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 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. |
Countries
United States
Participant flow
Recruitment details
This was a multi-center study conducted at study sites in the US.
Participants by arm
| Arm | Count |
|---|---|
| V117957 1 mg V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime | 38 |
| V117957 2 mg V117957 tablets taken orally at bedtime
V117957 tablets: V117957 tablets taken orally at bedtime | 38 |
| Placebo Placebo to match V117957 tablets taken orally at bedtime
Placebo: Tablets to match V117957 | 38 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | COVID-19 | 1 | 0 | 0 |
| Overall Study | Early Termination | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Non-compliance | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 4 |
Baseline characteristics
| Characteristic | V117957 1 mg | V117957 2 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 12.85 | 45.2 years STANDARD_DEVIATION 13.01 | 44.9 years STANDARD_DEVIATION 12.18 | 44.5 years STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 11 Participants | 6 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 26 Participants | 32 Participants | 89 Participants |
| Sex: Female, Male Female | 21 Participants | 16 Participants | 24 Participants | 61 Participants |
| Sex: Female, Male Male | 17 Participants | 22 Participants | 14 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 5 / 38 | 14 / 38 | 7 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 | 0 / 38 |
Outcome results
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Nights 20 / 21 | 50.56 Minutes | Standard Deviation 34.115 |
| V117957 1 mg | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Nights 1 / 2 | 48.64 Minutes | Standard Deviation 28.453 |
| V117957 1 mg | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Baseline | 100.88 Minutes | Standard Deviation 45.098 |
| V117957 2 mg | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Nights 1 / 2 | 42.44 Minutes | Standard Deviation 28.189 |
| V117957 2 mg | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Baseline | 99.70 Minutes | Standard Deviation 36.496 |
| V117957 2 mg | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Nights 20 / 21 | 46.17 Minutes | Standard Deviation 27.275 |
| Placebo | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Baseline | 103.51 Minutes | Standard Deviation 32.456 |
| Placebo | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Nights 20 / 21 | 64.43 Minutes | Standard Deviation 33.999 |
| Placebo | Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) | Nights 1 / 2 | 63.00 Minutes | Standard Deviation 29.349 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Nights 1 / 2 | 43.03 Minutes | Standard Deviation 38.542 |
| V117957 1 mg | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Baseline | 76.63 Minutes | Standard Deviation 34.305 |
| V117957 1 mg | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Nights 20 / 21 | 53.48 Minutes | Standard Deviation 47.123 |
| V117957 2 mg | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Nights 1 / 2 | 31.31 Minutes | Standard Deviation 20.593 |
| V117957 2 mg | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Baseline | 66.30 Minutes | Standard Deviation 25.653 |
| V117957 2 mg | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Nights 20 / 21 | 31.70 Minutes | Standard Deviation 25.709 |
| Placebo | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Baseline | 81.58 Minutes | Standard Deviation 48.928 |
| Placebo | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Nights 20 / 21 | 47.42 Minutes | Standard Deviation 31.165 |
| Placebo | Change From Baseline in Mean Latency to Persistent Sleep (LPS) | Nights 1 / 2 | 51.74 Minutes | Standard Deviation 37.243 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Mean Number of Awakenings (NAW) | Nights 20 / 21 | 9.29 Number of Awakenings | Standard Deviation 5.114 |
| V117957 1 mg | Change From Baseline in Mean Number of Awakenings (NAW) | Baseline | 10.70 Number of Awakenings | Standard Deviation 5.733 |
| V117957 1 mg | Change From Baseline in Mean Number of Awakenings (NAW) | Nights 1 / 2 | 8.25 Number of Awakenings | Standard Deviation 3.86 |
| V117957 2 mg | Change From Baseline in Mean Number of Awakenings (NAW) | Nights 1 / 2 | 9.62 Number of Awakenings | Standard Deviation 5.599 |
| V117957 2 mg | Change From Baseline in Mean Number of Awakenings (NAW) | Baseline | 14.05 Number of Awakenings | Standard Deviation 5.101 |
| V117957 2 mg | Change From Baseline in Mean Number of Awakenings (NAW) | Nights 20 / 21 | 10.63 Number of Awakenings | Standard Deviation 6.055 |
| Placebo | Change From Baseline in Mean Number of Awakenings (NAW) | Baseline | 10.32 Number of Awakenings | Standard Deviation 5.609 |
| Placebo | Change From Baseline in Mean Number of Awakenings (NAW) | Nights 20 / 21 | 10.28 Number of Awakenings | Standard Deviation 5.575 |
| Placebo | Change From Baseline in Mean Number of Awakenings (NAW) | Nights 1 / 2 | 10.20 Number of Awakenings | Standard Deviation 4.256 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Mean Sleep Efficiency (SE) | Nights 1 / 2 | 82.00 Percent | Standard Deviation 10.81 |
| V117957 1 mg | Change From Baseline in Mean Sleep Efficiency (SE) | Baseline | 64.54 Percent | Standard Deviation 11.502 |
| V117957 1 mg | Change From Baseline in Mean Sleep Efficiency (SE) | Nights 20 / 21 | 79.46 Percent | Standard Deviation 10.516 |
| V117957 2 mg | Change From Baseline in Mean Sleep Efficiency (SE) | Nights 1 / 2 | 85.55 Percent | Standard Deviation 7.953 |
| V117957 2 mg | Change From Baseline in Mean Sleep Efficiency (SE) | Baseline | 67.18 Percent | Standard Deviation 9.919 |
| V117957 2 mg | Change From Baseline in Mean Sleep Efficiency (SE) | Nights 20 / 21 | 84.89 Percent | Standard Deviation 7.456 |
| Placebo | Change From Baseline in Mean Sleep Efficiency (SE) | Baseline | 63.17 Percent | Standard Deviation 12.825 |
| Placebo | Change From Baseline in Mean Sleep Efficiency (SE) | Nights 20 / 21 | 78.38 Percent | Standard Deviation 8.89 |
| Placebo | Change From Baseline in Mean Sleep Efficiency (SE) | Nights 1 / 2 | 77.64 Percent | Standard Deviation 9.95 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Mean Total Sleep Time (TST) | Baseline | 309.87 Minutes | Standard Deviation 55.265 |
| V117957 1 mg | Change From Baseline in Mean Total Sleep Time (TST) | Nights 1 / 2 | 393.80 Minutes | Standard Deviation 51.677 |
| V117957 1 mg | Change From Baseline in Mean Total Sleep Time (TST) | Nights 20 / 21 | 381.65 Minutes | Standard Deviation 50.528 |
| V117957 2 mg | Change From Baseline in Mean Total Sleep Time (TST) | Nights 1 / 2 | 410.12 Minutes | Standard Deviation 38.771 |
| V117957 2 mg | Change From Baseline in Mean Total Sleep Time (TST) | Baseline | 323.11 Minutes | Standard Deviation 48.065 |
| V117957 2 mg | Change From Baseline in Mean Total Sleep Time (TST) | Nights 20 / 21 | 407.45 Minutes | Standard Deviation 35.765 |
| Placebo | Change From Baseline in Mean Total Sleep Time (TST) | Baseline | 303.24 Minutes | Standard Deviation 61.559 |
| Placebo | Change From Baseline in Mean Total Sleep Time (TST) | Nights 20 / 21 | 376.26 Minutes | Standard Deviation 42.64 |
| Placebo | Change From Baseline in Mean Total Sleep Time (TST) | Nights 1 / 2 | 372.68 Minutes | Standard Deviation 47.771 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Subjective Morning Sleepiness on Awakening | Nights 1 /2 | 2.23 score on a scale | Standard Deviation 0.87 |
| V117957 1 mg | Change From Baseline in Subjective Morning Sleepiness on Awakening | Baseline | 1.54 score on a scale | Standard Deviation 0.655 |
| V117957 1 mg | Change From Baseline in Subjective Morning Sleepiness on Awakening | Nights 20 / 21 | 2.52 score on a scale | Standard Deviation 0.979 |
| V117957 2 mg | Change From Baseline in Subjective Morning Sleepiness on Awakening | Nights 1 /2 | 2.19 score on a scale | Standard Deviation 0.847 |
| V117957 2 mg | Change From Baseline in Subjective Morning Sleepiness on Awakening | Baseline | 1.60 score on a scale | Standard Deviation 0.613 |
| V117957 2 mg | Change From Baseline in Subjective Morning Sleepiness on Awakening | Nights 20 / 21 | 2.69 score on a scale | Standard Deviation 1.158 |
| Placebo | Change From Baseline in Subjective Morning Sleepiness on Awakening | Baseline | 1.72 score on a scale | Standard Deviation 0.611 |
| Placebo | Change From Baseline in Subjective Morning Sleepiness on Awakening | Nights 20 / 21 | 2.81 score on a scale | Standard Deviation 0.937 |
| Placebo | Change From Baseline in Subjective Morning Sleepiness on Awakening | Nights 1 /2 | 2.24 score on a scale | Standard Deviation 0.695 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Subjective Number of Awakenings (sNAW) | Nights 1 / 2 | 1.87 Number of Awakenings | Standard Deviation 1.245 |
| V117957 1 mg | Change From Baseline in Subjective Number of Awakenings (sNAW) | Baseline | 2.49 Number of Awakenings | Standard Deviation 1.1 |
| V117957 1 mg | Change From Baseline in Subjective Number of Awakenings (sNAW) | Nights 20 / 21 | 1.42 Number of Awakenings | Standard Deviation 1.049 |
| V117957 2 mg | Change From Baseline in Subjective Number of Awakenings (sNAW) | Nights 1 / 2 | 2.14 Number of Awakenings | Standard Deviation 2.703 |
| V117957 2 mg | Change From Baseline in Subjective Number of Awakenings (sNAW) | Baseline | 2.24 Number of Awakenings | Standard Deviation 1.013 |
| V117957 2 mg | Change From Baseline in Subjective Number of Awakenings (sNAW) | Nights 20 / 21 | 1.30 Number of Awakenings | Standard Deviation 0.815 |
| Placebo | Change From Baseline in Subjective Number of Awakenings (sNAW) | Baseline | 2.37 Number of Awakenings | Standard Deviation 0.984 |
| Placebo | Change From Baseline in Subjective Number of Awakenings (sNAW) | Nights 20 / 21 | 1.66 Number of Awakenings | Standard Deviation 1.405 |
| Placebo | Change From Baseline in Subjective Number of Awakenings (sNAW) | Nights 1 / 2 | 2.63 Number of Awakenings | Standard Deviation 1.647 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Subjective Sleep Efficiency (sSE) | Nights 20 / 21 | 73.74 Percent | Standard Deviation 11.925 |
| V117957 1 mg | Change From Baseline in Subjective Sleep Efficiency (sSE) | Nights 1 / 2 | 73.26 Percent | Standard Deviation 14.436 |
| V117957 1 mg | Change From Baseline in Subjective Sleep Efficiency (sSE) | Baseline | 61.51 Percent | Standard Deviation 8.768 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Efficiency (sSE) | Nights 20 / 21 | 76.78 Percent | Standard Deviation 12.383 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Efficiency (sSE) | Nights 1 / 2 | 73.72 Percent | Standard Deviation 16.661 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Efficiency (sSE) | Baseline | 63.14 Percent | Standard Deviation 8.898 |
| Placebo | Change From Baseline in Subjective Sleep Efficiency (sSE) | Nights 20 / 21 | 75.88 Percent | Standard Deviation 11.743 |
| Placebo | Change From Baseline in Subjective Sleep Efficiency (sSE) | Baseline | 63.50 Percent | Standard Deviation 10.924 |
| Placebo | Change From Baseline in Subjective Sleep Efficiency (sSE) | Nights 1 / 2 | 71.53 Percent | Standard Deviation 10.229 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Nights 1 / 2 | 54.42 Minutes | Standard Deviation 29.031 |
| V117957 1 mg | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Baseline | 74.54 Minutes | Standard Deviation 30.022 |
| V117957 1 mg | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Nights 20 / 21 | 63.13 Minutes | Standard Deviation 32.74 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Nights 1 / 2 | 50.53 Minutes | Standard Deviation 32.579 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Baseline | 75.84 Minutes | Standard Deviation 31.274 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Nights 20 / 21 | 47.14 Minutes | Standard Deviation 24.289 |
| Placebo | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Baseline | 63.45 Minutes | Standard Deviation 19.795 |
| Placebo | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Nights 20 / 21 | 47.68 Minutes | Standard Deviation 33.17 |
| Placebo | Change From Baseline in Subjective Sleep Onset Latency (sSOL) | Nights 1 / 2 | 57.24 Minutes | Standard Deviation 28.375 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Subjective Sleep Quality (sSleep) | Nights 1 / 2 | 2.72 score on a scale | Standard Deviation 0.984 |
| V117957 1 mg | Change From Baseline in Subjective Sleep Quality (sSleep) | Baseline | 1.80 score on a scale | Standard Deviation 0.686 |
| V117957 1 mg | Change From Baseline in Subjective Sleep Quality (sSleep) | Nights 20 / 21 | 2.94 score on a scale | Standard Deviation 0.989 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Quality (sSleep) | Nights 1 / 2 | 2.92 score on a scale | Standard Deviation 1.004 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Quality (sSleep) | Baseline | 1.82 score on a scale | Standard Deviation 0.683 |
| V117957 2 mg | Change From Baseline in Subjective Sleep Quality (sSleep) | Nights 20 / 21 | 3.11 score on a scale | Standard Deviation 1.027 |
| Placebo | Change From Baseline in Subjective Sleep Quality (sSleep) | Baseline | 1.99 score on a scale | Standard Deviation 0.727 |
| Placebo | Change From Baseline in Subjective Sleep Quality (sSleep) | Nights 20 / 21 | 3.20 score on a scale | Standard Deviation 0.841 |
| Placebo | Change From Baseline in Subjective Sleep Quality (sSleep) | Nights 1 / 2 | 2.64 score on a scale | Standard Deviation 0.734 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Subjective Total Sleep Time (sTST) | Nights 1 / 2 | 355.82 Minutes | Standard Deviation 69.903 |
| V117957 1 mg | Change From Baseline in Subjective Total Sleep Time (sTST) | Baseline | 296.42 Minutes | Standard Deviation 45.586 |
| V117957 1 mg | Change From Baseline in Subjective Total Sleep Time (sTST) | Nights 20 / 21 | 366.14 Minutes | Standard Deviation 59.562 |
| V117957 2 mg | Change From Baseline in Subjective Total Sleep Time (sTST) | Nights 1 / 2 | 357.35 Minutes | Standard Deviation 80.198 |
| V117957 2 mg | Change From Baseline in Subjective Total Sleep Time (sTST) | Baseline | 304.60 Minutes | Standard Deviation 50.458 |
| V117957 2 mg | Change From Baseline in Subjective Total Sleep Time (sTST) | Nights 20 / 21 | 385.13 Minutes | Standard Deviation 71.181 |
| Placebo | Change From Baseline in Subjective Total Sleep Time (sTST) | Baseline | 315.05 Minutes | Standard Deviation 56.092 |
| Placebo | Change From Baseline in Subjective Total Sleep Time (sTST) | Nights 20 / 21 | 384.13 Minutes | Standard Deviation 58.83 |
| Placebo | Change From Baseline in Subjective Total Sleep Time (sTST) | Nights 1 / 2 | 350.64 Minutes | Standard Deviation 51.843 |
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.
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Population: \\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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Nights 1 / 2 | 63.77 Minutes | Standard Deviation 63.476 |
| V117957 1 mg | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Baseline | 92.51 Minutes | Standard Deviation 42.137 |
| V117957 1 mg | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Nights 20 / 21 | 51.53 Minutes | Standard Deviation 40.574 |
| V117957 2 mg | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Nights 1 / 2 | 59.48 Minutes | Standard Deviation 55.546 |
| V117957 2 mg | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Baseline | 85.93 Minutes | Standard Deviation 42.222 |
| V117957 2 mg | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Nights 20 / 21 | 54.21 Minutes | Standard Deviation 44.666 |
| Placebo | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Baseline | 83.49 Minutes | Standard Deviation 63.929 |
| Placebo | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Nights 20 / 21 | 46.84 Minutes | Standard Deviation 32.499 |
| Placebo | Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO) | Nights 1 / 2 | 55.72 Minutes | Standard Deviation 34.974 |
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.
Time frame: Baseline, Night 2, Night 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Night 2;10-hours postdose - Total correct responses | 51.6 Correct Responses | Standard Deviation 16.06 |
| V117957 1 mg | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Baseline - Total correct responses | 49.0 Correct Responses | Standard Deviation 17.82 |
| V117957 1 mg | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Night 21; 10-hours postdose - Total correct responses | 52.0 Correct Responses | Standard Deviation 16.67 |
| V117957 2 mg | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Night 2;10-hours postdose - Total correct responses | 51.7 Correct Responses | Standard Deviation 13.83 |
| V117957 2 mg | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Baseline - Total correct responses | 46.4 Correct Responses | Standard Deviation 15.85 |
| V117957 2 mg | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Night 21; 10-hours postdose - Total correct responses | 52.6 Correct Responses | Standard Deviation 18.65 |
| Placebo | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Baseline - Total correct responses | 46.2 Correct Responses | Standard Deviation 18.95 |
| Placebo | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Night 21; 10-hours postdose - Total correct responses | 54.3 Correct Responses | Standard Deviation 15.66 |
| Placebo | Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST). | Night 2;10-hours postdose - Total correct responses | 54.8 Correct Responses | Standard Deviation 13.58 |
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.
Time frame: Baseline, Night 2 (9- and 10-hours postdose), Night 21 (9- and 10-hours postdose)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 21 - 9 hours postdose | 4.1 score on a scale | Standard Deviation 1.99 |
| V117957 1 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 2 - 10 hours postdose | 3.8 score on a scale | Standard Deviation 1.94 |
| V117957 1 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Baseline | 4.3 score on a scale | Standard Deviation 2.3 |
| V117957 1 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 2 - 9 hours postdose | 4.2 score on a scale | Standard Deviation 1.94 |
| V117957 1 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 21 - 10 hours postdose | 3.8 score on a scale | Standard Deviation 2.02 |
| V117957 2 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 2 - 10 hours postdose | 4.0 score on a scale | Standard Deviation 2.03 |
| V117957 2 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Baseline | 4.4 score on a scale | Standard Deviation 2.23 |
| V117957 2 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 2 - 9 hours postdose | 4.7 score on a scale | Standard Deviation 2.17 |
| V117957 2 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 21 - 9 hours postdose | 4.5 score on a scale | Standard Deviation 2.34 |
| V117957 2 mg | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 21 - 10 hours postdose | 4.0 score on a scale | Standard Deviation 1.88 |
| Placebo | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 21 - 10 hours postdose | 3.1 score on a scale | Standard Deviation 1.31 |
| Placebo | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 21 - 9 hours postdose | 3.9 score on a scale | Standard Deviation 1.75 |
| Placebo | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Baseline | 4.4 score on a scale | Standard Deviation 2.09 |
| Placebo | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 2 - 10 hours postdose | 3.9 score on a scale | Standard Deviation 1.93 |
| Placebo | Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS) | Night 2 - 9 hours postdose | 4.3 score on a scale | Standard Deviation 2.06 |
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.
Time frame: Baseline, Night 2, Night 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Night 2 | 5.41 score on a scale | Standard Deviation 16.732 |
| V117957 1 mg | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Baseline | 13.54 score on a scale | Standard Deviation 23.612 |
| V117957 1 mg | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Night 21 | 2.02 score on a scale | Standard Deviation 15.075 |
| V117957 2 mg | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Night 2 | 5.46 score on a scale | Standard Deviation 14.674 |
| V117957 2 mg | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Baseline | 12.03 score on a scale | Standard Deviation 15.658 |
| V117957 2 mg | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Night 21 | 5.22 score on a scale | Standard Deviation 13.63 |
| Placebo | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Baseline | 11.80 score on a scale | Standard Deviation 16.863 |
| Placebo | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Night 21 | 1.58 score on a scale | Standard Deviation 16.305 |
| Placebo | Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief | Night 2 | 6.34 score on a scale | Standard Deviation 15.905 |
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).
Time frame: Baseline Compared to Washout/Follow-up Period (Nights 22 / 23)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| V117957 1 mg | Occurrence of Rebound Insomnia During the Washout/Follow-up Period | Washout/Follow-up Period | 78.82 Minutes | Standard Deviation 48.048 |
| V117957 1 mg | Occurrence of Rebound Insomnia During the Washout/Follow-up Period | Baseline | 100.88 Minutes | Standard Deviation 45.098 |
| V117957 2 mg | Occurrence of Rebound Insomnia During the Washout/Follow-up Period | Washout/Follow-up Period | 94.23 Minutes | Standard Deviation 58.961 |
| V117957 2 mg | Occurrence of Rebound Insomnia During the Washout/Follow-up Period | Baseline | 99.70 Minutes | Standard Deviation 36.496 |
| Placebo | Occurrence of Rebound Insomnia During the Washout/Follow-up Period | Baseline | 103.51 Minutes | Standard Deviation 32.456 |
| Placebo | Occurrence of Rebound Insomnia During the Washout/Follow-up Period | Washout/Follow-up Period | 65.03 Minutes | Standard Deviation 33.942 |
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.
Time frame: Nights 1 / 2, Nights 20 / 21
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| V117957 1 mg | Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | Responder - Nights 1 / 2 - Threshold 15 minutes | 29 Participants |
| V117957 1 mg | Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | Responder - Nights 20 / 21 - Threshold 15 minutes | 33 Participants |
| V117957 2 mg | Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | Responder - Nights 1 / 2 - Threshold 15 minutes | 33 Participants |
| V117957 2 mg | Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | Responder - Nights 20 / 21 - Threshold 15 minutes | 27 Participants |
| Placebo | Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | Responder - Nights 1 / 2 - Threshold 15 minutes | 30 Participants |
| Placebo | Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo | Responder - Nights 20 / 21 - Threshold 15 minutes | 25 Participants |