InsomniaPhase 2NCT04035200
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
A Phase 2 study testing V117957 tablets in people with Insomnia, run by Imbrium Therapeutics at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia
- What is being tested?
- V117957 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 17 sitesUnited States
- Study dates
- 23 Sep 2019to 6 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
NeuroTrials Research Inc
Atlanta, Georgia, 30328
SPRI Clinical Trials
Brooklyn, New York, 11235
Investigational Site
Chevy Chase, Maryland, 20815
CTI Clinical Research Center
Cincinnati, Ohio, 45212
St. Francis Medical Institute
Clearwater, Florida, 33765
Advanced Medical Trials
Georgetown, Texas, 78628
Sleep Disorders Centers of the Mid Atlantic
Glen Burnie, Maryland, 21061
California Clinical Trials Medical Group
Glendale, California, 91206
Research Centers of America
Hollywood, Florida, 33024
Wake Research - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, 89104
Research Centers of America, LLC
Miami, Florida, 33157
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Clinilabs Drug Development Corporation
New York, New York, 10019
Artemis Institute for Clinical Research
Riverside, California, 92503
Artemis Institute for Clinical Research
San Diego, California, 92103
CITrials
Santa Ana, California, 92705
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
About this study
Official title: A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of V117957 in Subjects With an Alcohol Use Disorder Who Are Experiencing Insomnia Associated With Alcohol Cessation
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.
- Conditions
- Insomnia
- Being tested
- V117957 tablets, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V117957 tabletsDrug
V117957 tablets taken orally at bedtime
PlaceboDrug
Tablets to match V117957
| Study group | Role | What they receive |
|---|---|---|
| V117957 1 mg | Experimental | V117957 tablets taken orally at bedtime Receives: Drug: V117957 tablets |
| V117957 2 mg | Experimental | V117957 tablets taken orally at bedtime Receives: Drug: V117957 tablets |
| Placebo | Placebo comparator | Placebo to match V117957 tablets taken orally at bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Nights 1 / 2, Nights 20 / 21
Secondary outcomes (16)
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.
Measured: Baseline, Nights 1 / 2, Nights 20 / 21
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Night 2, Night 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start23 Sep 2019
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imbrium Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035200
- Sponsor's protocol ID
- OAG2002
- Status last verified
- Sep 2023
- First submitted
- 25 Jul 2019
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37883189
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of V117957 in Subjects With an Alcohol Use Disorder Who Are Experiencing Insomnia Associated With Alcohol Cessation
- ClinicalTrials.gov ID
- NCT04035200
- Acronym / sponsor ID
- OAG2002
- Conditions
- Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Imbrium TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V117957 1 mg | Experimental | Drug: V117957 tabletsV117957 tablets taken orally at bedtime |
| V117957 2 mg | Experimental | Drug: V117957 tabletsV117957 tablets taken orally at bedtime |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match V117957 tablets taken orally at bedtime |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V117957 tabletsV117957 tablets taken orally at bedtime | Drug | V117957 1 mg, V117957 2 mg |
| PlaceboTablets to match V117957 | Drug | Placebo |
Primary outcome
Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG)
Time frame: 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.
16 secondary outcomes
Change From Baseline in Mean Sleep Efficiency (SE)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Mean Latency to Persistent Sleep (LPS)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Mean Total Sleep Time (TST)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Mean Number of Awakenings (NAW)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Subjective Sleep Quality (sSleep)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Subjective Total Sleep Time (sTST)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Subjective Wakefulness After Sleep Onset (sWASO)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Subjective Sleep Onset Latency (sSOL)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Subjective Sleep Efficiency (sSE)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Subjective Number of Awakenings (sNAW)
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Change From Baseline in Subjective Morning Sleepiness on Awakening
Time frame: Baseline, Nights 1 / 2, Nights 20 / 21
Proportion of Responders to V117957 1 mg and 2 mg Compared to Placebo
Time frame: Nights 1 / 2, Nights 20 / 21
Occurrence of Rebound Insomnia During the Washout/Follow-up Period
Time frame: Baseline Compared to Washout/Follow-up Period (Nights 22 / 23)
Next Day Residual Effects as Determined by Digit Symbol Substitution Test (DSST).
Time frame: Baseline, Night 2, Night 21
Next Day Residual Effects as Determined by Karolinska Sleepiness Scale (KSS)
Time frame: 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
Time frame: Baseline, Night 2, Night 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37883189Whiteside 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V117957 tablets in people with Insomnia, run by Imbrium Therapeutics at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline of Wakefulness After Sleep Onset (WASO) Measured by Polysomnography (PSG) (time frame: Baseline, Nights 1 / 2, Nights 20 / 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.