AzTrials
AzTrials

Idiopathic HypersomniaPhase 3NCT05156047

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

A Phase 3 study testing Open-label Pitolisant and Double-blind Pitolisant in people with Idiopathic Hypersomnia, run by Harmony Biosciences Management, Inc. at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Hypersomnia
What is being tested?
Open-label Pitolisant and Double-blind Pitolisant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
58 sitesUnited States
Study dates
25 May 2022to 8 Sep 2023
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is able to provide voluntary, written informed consent.
  • Has a current diagnosis of IH per International Classification of Sleep Disorders Third Edition criteria.
  • Male or female participant age ≥18 years at the time of Screening.
  • Has an Epworth Sleepiness Scale score of ≥12 at Screening and at Baseline (Visit 2).
  • Has a Patient Global Impression of Severity score of moderate, severe, or very severe at Screening and at Baseline (Visit 2).
  • For participants being treated for obstructive sleep apnea (OSA) or other hypoventilatory conditions, participants must be compliant as demonstrated by bilevel positive airway pressure/continuous positive airway pressure (BiPAP/CPAP) therapy with 30 days of data showing ≥4 hours of BiPAP/CPAP therapy per night for ≥70% of nights. If not on BiPAP/CPAP therapy, participants being treated for OSA must be compliant as determined by the Investigator with their medical device or oral appliance. Data must be from within 90 days prior to the Screening visit. Participants must agree to maintain compliance with their treatment for OSA throughout the duration of the study.
Show all 12Show fewer
  • If on a treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil):
  • Must be on a stable dose for at least 2 months prior to Screening and agree to continue the stable dose for the duration of the study.
  • If not on a stable dose for 2 months prior to Screening, washout for 5 half-lives or 14 days, whichever is longer, prior to Day 1 and agree to remain off these treatments until completion of the study.
  • A participant who is a female of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test at the Baseline Visit (Visit 2) and at the end of the Stable Dose Period (Visit 4) and agree to remain abstinent or use an effective method of non-hormonal contraception to prevent pregnancy for the duration of the study and for 21 days after final dose of study drug.
  • Must have a negative result on urine drug screen at the Screening Visit, Baseline Visit (Visit 2) and at the end of the Stable Dose Period (Visit 4), except for medications that are prescribed by a healthcare provider for medical conditions.
  • In the opinion of the Investigator, the participant is capable of understanding and complying with the protocol and administration of oral study drug.

Who cannot join

  • Has hypersomnia due to another medical disorder (for example, narcolepsy).
  • Has an Apnea Hypopnea Index of ≥10 as determined by the most recent sleep study or BiPAP/CPAP device readout.
  • Has a clinically significant hypoventilatory condition as determined by the Investigator.
  • Has a primary diagnosis of a psychiatric illness that is not well controlled.
  • Participants taking antidepressants who have not been on a stable dose of their antidepressant for at least 12 weeks prior to Screening; participants on a stable dose of their antidepressant for at least 12 weeks prior to Screening must agree to continue their stable dose for the duration of the study.
  • Experiences a mean of <6 hours of sleep per night based on sleep diary during Screening (participants need to record at least 7 nights within a 10-day period in their sleep diary within 14-days prior to the Baseline Visit [Visit 2]).
Show all 23Show fewer
  • Consistently consumes >600 mg of caffeine per day and is unable/unwilling to reduce caffeine intake to ≤600 mg per day for the duration of the study.
  • Does not agree to discontinue any prohibited medication or substance listed in the protocol.
  • Is currently or has previously used pitolisant.
  • Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 21 days after final dose of study drug.
  • Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 28 days or within 5 half-lives of the investigational medication (whichever is longer) prior to Screening.
  • Has a diagnosis of end-stage renal disease (estimated glomerular filtration rate [eGFR] of <15 milliliters [mL]/minute/1.73 square meter [m^2]) or severe hepatic impairment (Child-Pugh C).
  • Has a diagnosis of moderate or severe renal impairment (eGFR ≥15 to ≤59 mL/minute/1.73 m^2) or moderate hepatic impairment (Child-Pugh B) at Screening or at any time during the study.
  • Has a history of long corrected QT interval syndrome or corrected QT interval using Fridericia's formula (QTcF) >450 milliseconds (msec) for males or >470 msec for females (QTcF = QT / 3√ RR) at Screening.
  • Is receiving and is unable to discontinue a medication known to prolong the QT interval.
  • Is receiving a concomitant medication that is known to be a strong cytochrome P450 3A4 inducer, or a centrally acting histamine 1 receptor antagonist; participants who undergo a washout of these medications of at least 5 half-lives or one week (whichever is longer) may be enrolled in the study. Use of strong CYP2D6 inhibitors is allowed; however, for these participants the maximum permitted daily dose of pitolisant is 17.8 mg.
  • Is a known CYP2D6 poor metabolizer.
  • Has abnormal laboratory values at Screening that are clinically significant as determined by the Investigator.
  • Has initiated any new or change in allied health therapies or interventions that can interfere with the study outcomes within 28 days prior to Screening and at any time during the study, based on the Investigator's judgment.
  • Has a current or recent (within 1 year) history of a substance use disorder or dependence disorder, including alcohol, tobacco, and caffeine use disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
  • Has planned surgery during the study.
  • Has a significant risk of committing suicide or suicidality based on history; routine psychiatric examination; Investigator's judgment; or an answer of "yes" on any question other than questions 1 to 3 (for the previous month) or "yes" on any question in the suicidal behavior section (for the past year) of the Columbia-Suicide Severity Scale, Baseline/Screening.
  • Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to an unstable or uncontrolled medical condition or one that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study. This exclusion criterion applies not only to entry into the study, but also to continuation in the study, should such an unstable, uncontrolled, or serious medical condition arise.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • CardioVoyage

    Ardmore, Oklahoma, 73401

  • Neurotrials Research Inc.

    Atlanta, Georgia, 30328

  • FutureSearch Trials of Neurology LP

    Austin, Texas, 78731

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • Meris Clinical Research

    Brandon, Florida, 33511

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718

  • Medical University of South Carolina- Institute of Psychiatry

    Charleston, South Carolina, 29425

  • Advanced Center for Sleep Disorders

    Chattanooga, Tennessee, 37421

  • St. Luke's Sleep Medicine and Research Center

    Chesterfield, Missouri, 63017

  • Helene A. Emsellem MD PC

    Chevy Chase, Maryland, 20815

  • Northwestern University

    Chicago, Illinois, 60611

  • Intrepid Research, LLC

    Cincinnati, Ohio, 45245

  • St. Francis Medical Institute

    Clearwater, Florida, 33765

  • Rainbow Babies Children's Hospital

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Bogan Sleep Consultants

    Columbia, South Carolina, 29201

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • Research Carolina Elite LLC

    Denver, North Carolina, 28037

  • Ohio Sleep Medicine and Neuroscience Institute

    Dublin, Ohio, 43017

  • Duke University School of Medicine

    Durham, North Carolina, 27705

  • Minnesota Lung Center

    Edina, Minnesota, 55125

  • The Neurological Center of North GA

    Gainesville, Georgia, 30501

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • NorthShore Uni HealthSys-Glenbrook Hospital

    Glenview, Illinois, 60026

  • ARSM Research

    Huntersville, North Carolina, 28078

  • Cedars-Sinai Medical Towers

    Los Angeles, California, 90048

  • University of California- Los Angeles

    Los Angeles, California, 90095

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53719

  • Sleep Medicine Specialists of South Florida, PA

    Miami, Florida, 33126

  • North Star Medical Research

    Middleburg, Ohio, 44130

  • West Virginia University - Department of Neurology

    Morgantown, West Virginia, 26506

  • Northwell Health

    New Hyde Park, New York, 11042

  • Neurocare, INC

    Newton, Massachusetts, 02459

  • Children's Hospital of the King's Daughter

    Norfolk, Virginia, 23507

  • Lowcountry Lung Critical Care

    North Charleston, South Carolina, 29406

  • Great Plains Health

    North Platte, Nebraska, 69101

  • Norwalk Hospital Sleep Center

    Norwalk, Connecticut, 06850

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Brian Abaluck, LLC

    Paoli, Pennsylvania, 19301

  • Phoenix Medical Group

    Peoria, Arizona, 85381

  • OSF HealthCare Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Bronson Sleep Health

    Portage, Michigan, 49024

  • Central Texas Neurology Consultants, PA

    Round Rock, Texas, 78681

  • Sleep Medicine Specialists of California

    San Ramon, California, 94583

  • SDS Clinical Trials Inc.

    Santa Ana, California, 92705

  • Santa Monica Clinical Trials

    Santa Monica, California, 90404

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Clayton Sleep Institute

    St Louis, Missouri, 63123

  • Pasadena Center For Medical Research, LLC

    St. Petersburg, Florida, 33763

  • Clinical Neurophysiology Services

    Sterling Heights, Michigan, 48314

  • Comprehensive Sleep Medicine Associates

    Sugar Land, Texas, 77478

  • Northwest Houston Neurology and Sleep

    Tomball, Texas, 77375

  • Neurology Specialists of Monmouth County, PA

    West Long Branch, New Jersey, 07764

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

  • Florida Pediatric Research Institute

    Winter Park, Florida, 32789

  • Minnesota Lung Center

    Woodbury, Minnesota, 55125

  • Respiratory Specialists

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.

Key secondary objectives of this study are to assess the impact of pitolisant on:

Read more
  • Overall symptoms of IH
  • Participant impression of overall change in their symptoms of IH
  • Investigator assessment of overall disease severity of IH

Other secondary objectives of this study are to assess the impact of pitolisant in participants with IH on:

  • Participant impression of overall severity of their EDS
  • Functional status and activities of daily living
  • Sleep-related impairment
  • Sleep inertia
  • Cognitive function
Read the detailed description

This is a double-blind, placebo-controlled, randomized withdrawal study in adult participants (ages ≥18 years) with IH. The study will consist of a Screening Period (up to 28 days), an 8-week Open-Label Phase, and a 4-week Double-Blind Randomized Withdrawal Phase.

The Open-Label Phase of the study will be 8 weeks, which includes a 6-week Dose Optimization Period and a 2-week Stable Dose Period. In the Dose Optimization Period, all participants will be titrated to their optimal dose of open-label pitolisant (17.8 milligrams [mg] or 35.6 mg) based on Investigator assessment of tolerability and efficacy. The 3-week titration period will be followed by 3 weeks of flexible dosing (weeks 4-6) during which participants will continue to receive their optimal dose of 17.8 mg or 35.6 mg open-label pitolisant. Participants taking a strong cytochrome P450 2D6 (CYP2D6) inhibitor will be allowed in the study; however, for these participants, the maximum permitted daily dose of pitolisant will be 17.8 mg. Following completion of the 6-week Dose Optimization Period, participants will enter the 2-week Stable Dose Period. During this period, participants will remain at their optimal dose (the same dose they were taking at the end of the Dose Optimization Period [17.8 mg or 35.6 mg]) of open-label pitolisant for 2 weeks; dose adjustments are not allowed during the Stable Dose Period. At the end of the Stable Dose Period, participants will be defined as responders or non-responders. Responders will be randomized in a 1:1 ratio to receive blinded study drug (pitolisant or matching placebo) in the Double-Blind Randomized Withdrawal Phase of the study. Non-responders will not be randomized to treatment in the Double-Blind Randomized Withdrawal Phase and will complete two safety follow-up telephone contacts (TCs) at 15 (±3) days and 30 (+3) days after their final dose of open-label pitolisant.

During the Double-Blind Randomized Withdrawal Phase, participants (approximately 64 participants per treatment group) will receive blinded study drug either at the same dose they were taking in the Stable Dose Period (17.8 mg or 35.6 mg pitolisant) or matching placebo. The duration of the Double-Blind Randomized Withdrawal Phase will be 4 weeks (weeks 9-12); dose adjustments are not permitted during this phase of the study. After completion of the Double-Blind Randomized Withdrawal Phase (End-of Treatment Visit is on Day 84, the last day of blinded treatment), participants will complete two safety follow-up TCs with the site at 15 (±3) days and 30 (+3) days after their final dose of blinded study drug, which will include assessment for adverse events and concomitant medication use; alternatively, participants will have the opportunity to enroll in a long-term, open-label safety study under a separate protocol. Participants who opt to enroll into the long-term, open-label study will not complete the 15-day and 30-day follow-up TCs.

Being tested
Open-label Pitolisant, Double-blind Placebo, Double-blind Pitolisant
Keywords
Pitolisant, Histamine, Sleepiness
Medical subject headings
Idiopathic Hypersomnia, Sleepiness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open-label PitolisantDrug

    Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 millimeters (mm) in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.

    Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.

  • Double-blind PlaceboDrug

    Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.

  • Double-blind PitolisantDrug

    Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 mm in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.

    Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.

Study groups in NCT05156047
Study groupRoleWhat they receive
Double-blind PitolisantActive comparatorDouble-blind pitolisant administered once daily in the morning upon wakening for 4 weeks during the Double-Blind Randomized Withdrawal Phase
Receives: Drug: Double-blind Pitolisant
Double-blind PlaceboPlacebo comparatorMatching placebo administered once daily in the morning upon wakening for 4 weeks during the Double-Blind Randomized Withdrawal Phase
Receives: Drug: Double-blind Placebo
Open-label PitolisantExperimentalOpen-label pitolisant administered once daily in the morning upon wakening for 8 weeks during the Open-Label Phase
Receives: Drug: Open-label Pitolisant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Epworth Sleepiness Scale (ESS) Score From Week 8 to Week 12

    The Epworth Sleepiness Scale (ESS) is an 8-item, 4-point rating scale that asks participants to rate the likelihood of falling asleep over the past week. The rating scale ranges from 0 (no chance of dozing) to 3 (high chance of dozing). The total score is calculated by summing the item level ratings. Total scores range from 0 to 24. Higher point totals represent more severe daytime sleepiness.

    Measured: Week 8 to Week 12

Secondary outcomes (10)

  1. Change in Idiopathic Hypersomnia Severity Scale (IHSS) From Week 8 to Week 12

    The Idiopathic Hypersomnia Severity Scale (IHSS) is a self-administered questionnaire with a total of 14 items that assess long sleep duration and sleep inertia (5 items), daytime functioning (7 items), and napping (2 items). All items are scored from 0 to 3 or from 0 to 4. The total score is a sum of the item scores. The total score ranges from 0 to 50. A higher score indicates more severe and frequent symptoms.

    Measured: Week 8 to Week 12

  2. Proportion of Participants Who Worsened on the Patient Global Impression of Change for Idiopathic Hypersomnia (PGI-C [IH]) From Week 8 to Week 12

    The Patient Global Impression of Change for Idiopathic Hypersomnia (PGI-C [IH]) is a single-item questionnaire that assesses a participant's overall impression of the change in their symptoms of IH. The scale asks participants to rate their overall impression of the change in their symptoms of IH since a specific timepoint on a 5-point verbal rating scale ranging from "much better" to "much worse."

    Measured: Week 8 to Week 12

  3. Change in Clinical Global Impression of Severity for IH (CGI-S [IH]) From Week 8 to Week 12

    The CGI-S (IH) is an investigator-rated assessment. It uses a single-item, 5-point Likert-type rating scale that ranges from: none (1); mild (2); moderate (3); severe (4); very severe (5). An assessment of less severe symptoms represents an improvement in the investigator's perception of the participant's overall clinical status related to idiopathic hypersomnia and is reflected by a decrease in score.

    Measured: Week 8 to Week 12

  4. Change in Patient Global Impression of Severity Scale for Excessive Daytime Sleepiness (PGI-S [EDS]) From Week 8 to Week 12

    The Patient Global Impression of Severity for Excessive Daytime Sleepiness (PGI-S [EDS]) asks participants to rate their overall impression of the severity of their EDS over the past 7 days on a 5-point verbal rating scale ranging from "none" to "very severe". Scores are: 1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe.

    Measured: Week 8 to Week 12

  5. Change in Functional Outcomes of Sleep Questionnaire 10-Item Version (FOSQ-10) From Week 8 to Week 12

    The Functional Outcomes of Sleep Questionnaire 10-Item Version (FOSQ-10) consists of 10 items assessing the impact of sleepiness on daily functioning across 5 domains: vigilance, general productivity, social outcomes, intimacy, and activity level. Each item is rated on a scale of 0 (activity not performed for other reasons), 1 (extreme difficulty), 2 (moderate difficulty), 3 (a little difficulty), and 4 (no difficulty). The FOSQ-10 total score is calculated by multiplying the mean of the subscale scores by five, with final scores ranging from 5-20. Higher scores correspond to less impairment/symptomatic severity.

    Measured: Week 8 to Week 12

  6. Change in Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form 8a (PROMIS-SRI SF 8a) From Week 8 to Week 12

    The PROMIS-SRI SF 8a is a self-report measure that includes 8 questions designed to assess a participant's perceptions of their waking alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness over the past week. Responses are rated using a 5-point scale, with responses ranging from: 1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much, with average scores ranging from 8 to 40. Raw scores are converted to a T-score using the conversion table from the PROMIS-SRI Scoring Manual. Raw score ranges from 8 to 40; T-score ranges from 30 to 80.1. Higher scores represent greater impairment.

    Measured: Week 8 to Week 12

  7. Change in Sleep Inertia Questionnaire (SIQ) From Week 8 to Week 12

    The Sleep Inertia Questionnaire (SIQ) consists of 21 questions that assess sleep inertia. Each question is rated on a scale of 1 to 5, where: 1=not at all; 2=a little; 3=somewhat; 4=often; 5=all the time. Total scores range from 21 to 105. Higher scores represent greater sleep inertia.

    Measured: Week 8 to Week 12

  8. Change in Cogstate One Back Test (ONB) From Week 8 to Week 12

    Cognition was assessed using the Cogstate Computerized Cognitive Battery tests. The cognitive domain of working memory was assessed specifically with the One Back Test (ONB), which measures the speed of the participant's response. Results are reported as the mean of the common logarithm (log 10) transformed reaction time (in milliseconds [msec]) for correct responses. A decrease in score represents an increase in working memory performance.

    Measured: Week 8 to Week 12

  9. Change in Cogstate Identification Test (IDN) From Week 8 to Week 12

    Cognition was assessed using the Cogstate Computerized Cognitive Battery tests. The cognitive domain of visual attention was assessed using the Identification Test (IDN). Results reported as the mean of the log 10 transformed reaction time for correct responses. A decrease in score represents an increase in visual attention performance.

    Measured: Week 8 to Week 12

  10. Change in Cogstate Detection Test (DET) From Week 8 to Week 12

    Cognition was assessed using the Cogstate Computerized Cognitive Battery tests. The cognitive domain of psychomotor function was assessed specifically using the Detection Test (DET). The test measures the speed of the participant's response. Results reported as the mean of the log 10 transformed reaction time (msec) for the correct responses. A decrease in score represents an increase in psychomotor function performance.

    Measured: Week 8 to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start25 May 2022
  3. Primary completion8 Sep 2023
  4. Study completion8 Sep 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind, randomized withdrawal
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156047
Sponsor's protocol ID
HBS-101-CL-010
Status last verified
Sep 2026
First submitted
1 Dec 2021
Last updated
25 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Open-label Pitolisant and Double-blind Pitolisant in people with Idiopathic Hypersomnia, run by Harmony Biosciences Management, Inc. at 58 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 12 inclusion and 23 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 Sep 2026). 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 in Epworth Sleepiness Scale (ESS) Score From Week 8 to Week 12 (time frame: Week 8 to Week 12). 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 NCT05156047.

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 25 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in