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CompletedNCT04035200Updated Sep 18, 2023Results posted

Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation

A Phase 2 interventional study of V117957 tablets and Placebo in Insomnia, sponsored by Imbrium Therapeutics. Completed at 17 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Imbrium Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Insomnia
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 114 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Imbrium Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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/exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    V117957 1 mg

    V117957 tablets taken orally at bedtime

    Drug: V117957 tablets

  • Experimental
    V117957 2 mg

    V117957 tablets taken orally at bedtime

    Drug: V117957 tablets

  • Placebo comparator
    Placebo

    Placebo to match V117957 tablets taken orally at bedtime

    Drug: Placebo

Interventions

  • DrugV117957 tablets

    V117957 tablets taken orally at bedtime

  • DrugPlacebo

    Tablets to match V117957

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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)

  14. 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

  15. 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)

  16. 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

07

Results

Posted Sep 18, 2023

Participant flow

This was a multi-center study conducted at study sites in the US.

Participant flow — Overall Study
MilestoneV117957 1 mgV117957 2 mgPlacebo
Started383838
Completed363134
Not completed274
Withdrew: Lost to follow-up010
Withdrew: Withdrawal by subject144
Withdrew: Covid-19100
Withdrew: Early termination010
Withdrew: Non-compliance010

Outcome measures

PrimaryChange 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
Reported as:
Mean · Minutes
Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)
MinutesV117957 1 mgV117957 2 mgPlacebo
Baseline100.88 ± 45.09899.70 ± 36.496103.51 ± 32.456
Nights 1 / 248.64 ± 28.45342.44 ± 28.18963.00 ± 29.349
Nights 20 / 2150.56 ± 34.11546.17 ± 27.27564.43 ± 33.999
SecondaryChange 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
Reported as:
Mean · Percent
Change From Baseline in Mean Sleep Efficiency (SE)
PercentV117957 1 mgV117957 2 mgPlacebo
Baseline64.54 ± 11.50267.18 ± 9.91963.17 ± 12.825
Nights 1 / 282.00 ± 10.81085.55 ± 7.95377.64 ± 9.950
Nights 20 / 2179.46 ± 10.51684.89 ± 7.45678.38 ± 8.890
SecondaryChange 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
Reported as:
Mean · Minutes
Change From Baseline in Mean Latency to Persistent Sleep (LPS)
MinutesV117957 1 mgV117957 2 mgPlacebo
Baseline76.63 ± 34.30566.30 ± 25.65381.58 ± 48.928
Nights 1 / 243.03 ± 38.54231.31 ± 20.59351.74 ± 37.243
Nights 20 / 2153.48 ± 47.12331.70 ± 25.70947.42 ± 31.165
SecondaryChange 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
Reported as:
Mean · Minutes
Change From Baseline in Mean Total Sleep Time (TST)
MinutesV117957 1 mgV117957 2 mgPlacebo
Baseline309.87 ± 55.265323.11 ± 48.065303.24 ± 61.559
Nights 1 / 2393.80 ± 51.677410.12 ± 38.771372.68 ± 47.771
Nights 20 / 21381.65 ± 50.528407.45 ± 35.765376.26 ± 42.640
SecondaryChange 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
Reported as:
Mean · Number of Awakenings
Change From Baseline in Mean Number of Awakenings (NAW)
Number of AwakeningsV117957 1 mgV117957 2 mgPlacebo
Baseline10.70 ± 5.73314.05 ± 5.10110.32 ± 5.609
Nights 1 / 28.25 ± 3.8609.62 ± 5.59910.20 ± 4.256
Nights 20 / 219.29 ± 5.11410.63 ± 6.05510.28 ± 5.575
SecondaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline in Subjective Sleep Quality (sSleep)
score on a scaleV117957 1 mgV117957 2 mgPlacebo
Baseline1.80 ± 0.6861.82 ± 0.6831.99 ± 0.727
Nights 1 / 22.72 ± 0.9842.92 ± 1.0042.64 ± 0.734
Nights 20 / 212.94 ± 0.9893.11 ± 1.0273.20 ± 0.841
SecondaryChange 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
Reported as:
Mean · Minutes
Change From Baseline in Subjective Total Sleep Time (sTST)
MinutesV117957 1 mgV117957 2 mgPlacebo
Baseline296.42 ± 45.586304.60 ± 50.458315.05 ± 56.092
Nights 1 / 2355.82 ± 69.903357.35 ± 80.198350.64 ± 51.843
Nights 20 / 21366.14 ± 59.562385.13 ± 71.181384.13 ± 58.830
SecondaryChange 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
Reported as:
Mean · Minutes
Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO)
MinutesV117957 1 mgV117957 2 mgPlacebo
Baseline92.51 ± 42.13785.93 ± 42.22283.49 ± 63.929
Nights 1 / 263.77 ± 63.47659.48 ± 55.54655.72 ± 34.974
Nights 20 / 2151.53 ± 40.57454.21 ± 44.66646.84 ± 32.499
SecondaryChange 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
Reported as:
Mean · Minutes
Change From Baseline in Subjective Sleep Onset Latency (sSOL)
MinutesV117957 1 mgV117957 2 mgPlacebo
Baseline74.54 ± 30.02275.84 ± 31.27463.45 ± 19.795
Nights 1 / 254.42 ± 29.03150.53 ± 32.57957.24 ± 28.375
Nights 20 / 2163.13 ± 32.74047.14 ± 24.28947.68 ± 33.170
SecondaryChange 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
Reported as:
Mean · Percent
Change From Baseline in Subjective Sleep Efficiency (sSE)
PercentV117957 1 mgV117957 2 mgPlacebo
Baseline61.51 ± 8.76863.14 ± 8.89863.50 ± 10.924
Nights 1 / 273.26 ± 14.43673.72 ± 16.66171.53 ± 10.229
Nights 20 / 2173.74 ± 11.92576.78 ± 12.38375.88 ± 11.743
SecondaryChange 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
Reported as:
Mean · Number of Awakenings
Change From Baseline in Subjective Number of Awakenings (sNAW)
Number of AwakeningsV117957 1 mgV117957 2 mgPlacebo
Baseline2.49 ± 1.1002.24 ± 1.0132.37 ± 0.984
Nights 1 / 21.87 ± 1.2452.14 ± 2.7032.63 ± 1.647
Nights 20 / 211.42 ± 1.0491.30 ± 0.8151.66 ± 1.405
SecondaryChange 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
Reported as:
Mean · score on a scale
Change From Baseline in Subjective Morning Sleepiness on Awakening
score on a scaleV117957 1 mgV117957 2 mgPlacebo
Baseline1.54 ± 0.6551.60 ± 0.6131.72 ± 0.611
Nights 1 /22.23 ± 0.8702.19 ± 0.8472.24 ± 0.695
Nights 20 / 212.52 ± 0.9792.69 ± 1.1582.81 ± 0.937
SecondaryProportion 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
Reported as:
Count of participants · Participants
Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo
ParticipantsV117957 1 mgV117957 2 mgPlacebo
Responder - Nights 1 / 2 - Threshold 15 minutes293330
Responder - Nights 20 / 21 - Threshold 15 minutes332725
SecondaryOccurrence 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)
Reported as:
Mean · Minutes
Occurrence of Rebound Insomnia During the Washout/Follow-up Period
MinutesV117957 1 mgV117957 2 mgPlacebo
Baseline100.88 ± 45.09899.70 ± 36.496103.51 ± 32.456
Washout/Follow-up Period78.82 ± 48.04894.23 ± 58.96165.03 ± 33.942
SecondaryNext 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
Reported as:
Mean · Correct Responses
Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST).
Correct ResponsesV117957 1 mgV117957 2 mgPlacebo
Baseline - Total correct responses49.0 ± 17.8246.4 ± 15.8546.2 ± 18.95
Night 2;10-hours postdose - Total correct responses51.6 ± 16.0651.7 ± 13.8354.8 ± 13.58
Night 21; 10-hours postdose - Total correct responses52.0 ± 16.6752.6 ± 18.6554.3 ± 15.66
SecondaryNext 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)
Reported as:
Mean · score on a scale
Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)
score on a scaleV117957 1 mgV117957 2 mgPlacebo
Baseline4.3 ± 2.304.4 ± 2.234.4 ± 2.09
Night 2 - 9 hours postdose4.2 ± 1.944.7 ± 2.174.3 ± 2.06
Night 2 - 10 hours postdose3.8 ± 1.944.0 ± 2.033.9 ± 1.93
Night 21 - 9 hours postdose4.1 ± 1.994.5 ± 2.343.9 ± 1.75
Night 21 - 10 hours postdose3.8 ± 2.024.0 ± 1.883.1 ± 1.31
SecondaryNext 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
Reported as:
Mean · score on a scale
Next Day Residual Effects as Determined by Profile of Mood States (POMS) - Brief
score on a scaleV117957 1 mgV117957 2 mgPlacebo
Baseline13.54 ± 23.61212.03 ± 15.65811.80 ± 16.863
Night 25.41 ± 16.7325.46 ± 14.6746.34 ± 15.905
Night 212.02 ± 15.0755.22 ± 13.6301.58 ± 16.305

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
V117957 1 mg0/38 (0%)0/38 (0%)5/38 (13.2%)
V117957 2 mg0/38 (0%)0/38 (0%)14/38 (36.8%)
Placebo0/38 (0%)0/38 (0%)7/38 (18.4%)
Most frequent other events
Most frequent other events
EventV117957 1 mgV117957 2 mgPlacebo
SomnolenceNervous system disorders2/3810/380/38
HeadacheNervous system disorders3/381/382/38
NauseaGastrointestinal disorders2/381/383/38
FatigueGeneral disorders0/382/382/38
Blood triglycerides increasedInvestigations0/380/382/38

Baseline characteristics

Age, Continuous
Age, Continuous(years)V117957 1 mgV117957 2 mgPlaceboTotal
Mean43.3 ± 12.8545.2 ± 13.0144.9 ± 12.1844.5 ± 12.60
Sex: Female, Male
Sex: Female, Male(Participants)V117957 1 mgV117957 2 mgPlaceboTotal
Female21162461
Male17221453
Race (NIH/OMB)
Race (NIH/OMB)(Participants)V117957 1 mgV117957 2 mgPlaceboTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American611623
White31263289
More than one race1102
Unknown or Not Reported0000
08

Study locations

17 sites
  • California Clinical Trials Medical Group
    Glendale, California 91206, United States
  • Artemis Institute for Clinical Research
    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
  • Innovative Clinical Research, Inc.
    Miami Lakes, Florida 33016, United States
  • Research Centers of America, LLC
    Miami, Florida 33157, 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
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 27, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04035200
Lead sponsor
Imbrium Therapeutics
Collaborators
Purdue Pharma LP
Responsible party
Sponsor
First posted
Jul 29, 2019
Start date
Sep 23, 2019
Primary completion
Nov 6, 2020
Completion
Nov 6, 2020
Results posted
Sep 18, 2023
Last update
Sep 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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