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EDSPhase 3NCT07675135

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

A Phase 3 study testing HBS-301 in people with EDS and Cataplexy, run by Harmony Biosciences Management, Inc. at 53 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
EDS, Cataplexy, Fatigue
What is being tested?
HBS-301
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
53 sitesin 2 countries
Study dates
4 Jun 2026to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
  • Has EDS.
  • If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.

Who cannot join

  • Has hypersomnia due to another medical disorder.
  • Has a history of pitolisant use within 5 half-lives prior to Screening.
  • Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
  • Has any history of bipolar disorder or psychosis
  • Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
  • Has a body surface area-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
  • Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).

Trial locations and contacts

53 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Michelle Manuel contact

847-903-4610

clinicaltrials@harmonybiosciences.com

Katie Wilmsen contact

443-309-5556

clinicaltrials@harmonybiosciences.com

53 sites in 2 countries

United States51 sites, 51 recruiting

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

    Rachel Grossman, (215) 957-9250, rachelgrossman.ana@gmail.com

    John Khoury, MD

    Recruiting

  • Neurology Care

    Ardmore, Oklahoma, 73401

    Maaz Ghani, (210) 363-5481, mghani@sunbeamresearch.com

    Baha Abu-Esheh, MD

    Not yet recruiting

  • Neurotrials Research Inc

    Atlanta, Georgia, 30328

    Shriya Parekh, 404-851-9934, sparekh@neurotrials.com

    Dennis Lacey, MD

    Recruiting

  • Aayus Research

    Austin, Texas, 78731

    Maria-Fernanda Gamero, (803) 606-2052, Maria@aayus.co

    Bhavim Desai, MD

    Recruiting

  • Sleep Disorders Center of Alabama

    Birmingham, Alabama, 35213

    Joseph Wright, (205) 599-1020, jwright@sleepalabama.com

    Robert Doekel, MD

    Not yet recruiting

  • Alpine Clinical Research Center, Inc

    Boulder, Colorado, 80301

    Federica Bresciani, (601) 520-1333, fika@alpineresearch.com

    John R Harsh, PhD

    Recruiting

  • Lowcountry Lung and Critical Care PA

    Charleston, South Carolina, 29406

    Courtney Arnold, (843) 572-8545, carnold@lowcountrylung.com

    Thomas D Kaelin Jr, DO

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Brooke Cameron, 843-876-9262, camerobr@musc.edu

    Thomas Uhde, MD

    Not yet recruiting

  • St. Lukes Sleep Medicine and Research Center

    Chesterfield, Missouri, 63017

    Kimberly Allen-Bowzer, (314) 205-6011, SLHSleepResearch@stlukes-stl.com

    Michael McLeland, PhD

    Recruiting

  • Intrepid Research, LLC

    Cincinnati, Ohio, 45245

    Tiffany Schira, (513) 977-8891, tschira@intrepidresearch.md

    Bruce C Corser, MD

    Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Alex Piczer, (216) 445-2990, piczera@ccf.org

    Nancy Foldvary-Schaefer, DO

    Not yet recruiting

  • Delta Waves LLC

    Colorado Springs, Colorado, 80918

    Emma Gallagher, (719) 262-9283, egallagher@deltawaves.org

    Jonathan Olin, MD

    Recruiting

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201

    Lorraine Potts, (803) 251-3093, Lorraine.Potts@bogansleep.com

    Richard Bogan, MD

    Recruiting

  • Southwest Family Medicine

    Dallas, Texas, 75235

    Safia Shaikh, (469) 893-1242, sshaikh@swmedicalgroup.com

    Chrisette Dharma, MD

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17821

    Cheryl Pysher, (570) 271-8254, crpysher@geisinger.edu

    Anne Marie Morse, DO

    Not yet recruiting

  • Research Carolina Elite LLC

    Denver, North Carolina, 28037

    Heather Micun, RMA, CRC, 704-817-2200, Heather@researchcarolinaelite.com

    704-817-2200

    Not yet recruiting

  • Infinity Medical Research Inc

    East Providence, Rhode Island, 02914

    Patricia Mello, (508) 998-3041, pmello@infinitymedicalresearch.com

    Curtis Mello, MD

    Not yet recruiting

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

    James Stevens, (260) 436-2416, pcase@iuhealth.org

    James Stevens, MD

    Not yet recruiting

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

    Melissa Lanham, 704-675-7144, mlanham@crgastonia.com

    Anup Banerjee, MD

    Recruiting

  • NorthShore University HealthSystem

    Glenview, Illinois, 60026

    Anna Pham, (847) 570-2570, Anna.Pham@endeavorhealth.org

    Mari Viola-Saltzman, DO

    Not yet recruiting

  • Stern Research Partners

    Huntersville, North Carolina, 28078

    Felix Kurniawan, 704-659-0090, felix@arsmnc.com

    Thomas Stern, MD

    Recruiting

  • University of Kansas Hospital Main Campus

    Kansas City, Kansas, 66160

    Whitney Theis, (913) 588-6045, wtheis2@kumc.edu

    Damien Stevens, MD

    Not yet recruiting

  • West Coast Pulmonary & Sleep Disorders Center

    Lancaster, California, 93534

    Stephanie Nava, 805-483-1185, snava@fomatmedical.com

    Raj Bhatia, MD

    Not yet recruiting

  • Santa Monica Clinical Trials

    Los Angeles, California, 90025

    Samantha Montanez, (310) 586-0843, smontanez@smclinicaltrials.com

    Daniel Norman, MD

    Recruiting

  • Sleep Practitioners, LLC

    Macon, Georgia, 31210

    Noelle Williams, (478) 745-5779, nwilliams@sleeppractitioners.com

    Charles C Wells, Jr, MD

    Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53719

    Ahmad Allen, (608) 232-3333, aallen45@wisc.edu

    David Plante, MD, PhD

    Not yet recruiting

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069

    Rupa Krishna, (972) 838-1892, rkrishna@mpsleepcenter.com

    Shahrukh Kureishy, MD

    Not yet recruiting

  • PharmaDev Clinical Research Institute, LLC

    Miami, Florida, 33176

    Rolando Rodriguez, (305) 420-5636, rrodriguez@pharmadevresearch.com

    Edward Mezerhane, MD

    Recruiting

  • Patient First MD

    Middletown, New Jersey, 07748

    Avraham Tuvy, (732) 629-9699, tuvya@patientfirstmd.com

    Matthew Davis, MD

    Not yet recruiting

  • Springhill Medical Center

    Mobile, Alabama, 36608

    Kennedy Green, (251) 278-6022, kennedy.green@amr-clinical.com

    Michael Ledet, MD

    Not yet recruiting

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

    Lauren Chase, 304-598-4000, lauren.chase@wvumedicine.org

    Mouhannad Azzouz, MD

    Not yet recruiting

  • K2 Medical Research - Nashville

    Nashville, Tennessee, 37204

    Francesca McKay, (615) 208-5252, francesca.mckay@k2med.com

    Joshua Lennon, MD

    Not yet recruiting

  • Northwell Health Physician Partners

    New Hyde Park, New York, 11042

    Kirendra Pasram, (516)-465-5441, kpasram1@northwell.edu

    Harly Greenbergh, MD

    Not yet recruiting

  • Henry Ford Medical Center

    Novi, Michigan, 48377

    Michaela Mogle, (248) 344-6672, mmogle1@hfhs.org

    Christopher Drake, PhD

    Not yet recruiting

  • Phoenix Medical Group, PC

    Peoria, Arizona, 85381

    Daniel Kasenovich, (623) 583-6542, dkasenovich@phxresearch.com

    Robert Orr, DO

    Recruiting

  • OSF St Francis Medical Center

    Peoria, Illinois, 61606

    Kimberly Hartwig, (309) 672-5682, kimberly.hartwig@osfhealthcare.org

    Patrick Whitten, MD

    Not yet recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Steve Swanger, (412) 383-0607, swangersm2@upmc.edu

    Venkatesh Krishnamurthy, MD

    Not yet recruiting

  • Stanford Center for Sleep Sciences and Medicine

    Redwood City, California, 94063

    Sara Lomba, (650) 799-1565, slomba@stanford.edu

    Oliver Sum Ping, MD

    Recruiting

  • Southeast Lung Associates Research

    Rincon, Georgia, 31326

    Lisa Rodnicki, (912) 826-3927, lisa.rodnicki@centricityresearch.com

    Maria Mascolo, MD

    Recruiting

  • Sleep Therapy & Research Center

    San Antonio, Texas, 78229

    Erin Marshall, (210) 614-6000, marshall.erin@sleeptrc.com

    Nagwa Lamaie, MD

    Recruiting

  • HasResearch

    San Antonio, Texas, 78240

    Kimberly Rosales, (210) 614-7711, kimberly.rosales@hasresearch.com

    Hernan Salazar, DO

    Not yet recruiting

  • University of California San Francisco

    San Francisco, California, 94107

    Kyra Powers, (415) 823-3227, kyra.powers@ucsf.edu

    Andrew Krystal, MD

    Not yet recruiting

  • Trial Site Solutions

    San Ramon, California, 94583

    Phil Strauss, (925) 415-5353, phil@sleepmds.com

    Haramandeep Singh, MD

    Recruiting

  • Revive Research Institute, Inc

    Southfield, Michigan, 48075

    Abhishek Dhillon, (248) 564-1485, adhillon@rev-research.com

    Syed Raza, MD

    Recruiting

  • Sleep and Performance Research Center

    Spokane, Washington, 99202

    Olivia Brooks, (509) 358-7754, olivia.brooks@wsu.edu

    Devon Hansen, PhD

    Recruiting

  • Clinical Neurophysiology Services

    Sterling Heights, Michigan, 48314

    Jessica Austin, (586)-254-0707, austinj@sleepandattentiondisorders.com

    Shaffi Kanjwal, MD

    Recruiting

  • Clinical Research Institute Stockbridge

    Stockbridge, Georgia, 30281

    Beverley Jenkins, (678) 782-5358, bjenkins@clinicalresearchinstitute.us

    Phillip Nowlin, MD

    Recruiting

  • Tricoastal Narcolepsy and Sleep Disorders Center

    Sugar Land, Texas, 77478

    Natalia Dubock, (832) 210-3850, research@tricoastalsleep.com

    Gerry Meskill, MD

    Recruiting

  • TPMG Clinical Research

    Williamsburg, Virginia, 23188

    Gabrielle Land, (757) 707-3503, Gabrielle.Land@tpmgpc.com

    Richard Parisi, MD

    Not yet recruiting

  • Florida Pediatric Sleep Disorders Institute

    Winter Park, Florida, 32789

    Heidi Patenaude, (407) 898-2767, heidi@ajayihealthcare.com

    Akinyemi O Ajayi, MD

    Recruiting

  • Berks Schuylkill Respiratory Specialists

    Wyomissing, Pennsylvania, 19610

    Lisa Hill, (610) 685-5864, lhill@lungmd.net

    Alec Platt, MD

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • AMNDX Inc

    Markham, Ontario, M5S 3A3

    Urszula Lamoureux, 416-435-6244, urszula@amndx.ca

    Alan Lowe

    Recruiting

  • Jodha Tishon Inc

    Toronto, Ontario, M5S 3A3

    Naheed Hossain, (416) 551-8296, naheedkhossain@jodhatishon.com

    Colin Shapiro

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Read the detailed description

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating EDS, cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Approximately 258 participants are planned for randomization into the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension Period (1 year), and 30 days of safety follow-up.

Being tested
HBS-301, Placebo
Keywords
pitolisant, HBS-301, narcolepsy, EDS, cataplexy, fatigue
Medical subject headings
Cataplexy, Fatigue, Narcolepsy

What participants receive

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

  • HBS-301Drug

    Also called pitolisant delayed-release

    HBS-301 tablet

  • PlaceboOther

    Placebo tablet

Study groups in NCT07675135
Study groupRoleWhat they receive
Double-Blind Treatment Period HBS-301ExperimentalHBS-301 tablets administered once daily in the morning upon wakening
Receives: Drug: HBS-301
Double-blind Treatment Period PlaceboPlacebo comparatorMatching placebo tablets administered once daily in the morning upon wakening
Receives: Other: Placebo
Open-Label Extension Period HBS-301ExperimentalHBS-301 tablets administered once daily in the morning upon wakening
Receives: Drug: HBS-301

What is being measured

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

  1. Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)

    The ESS is an 8-item, 4-point rating scale.

    Measured: Baseline to end of Double-Blind Treatment Period (8 weeks)

Secondary outcomes (19)

  1. Change in Weekly Rate of Cataplexy (WRC) in participants with an average WRC of ≥3 over 2 consecutive weeks at Screening

    The WRC is the average number of cataplexy attacks per week.

    Measured: End of the Double-Blind Treatment Period (8 weeks)

  2. Change in sleepiness/wakefulness measured by the Maintenance of Wakefulness Test (MWT)

    The MWT consists of a series of 20-minute to 40-minute trials spaced 2 hours apart and is used to measure an individual's ability to stay awake.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  3. Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS-Fatigue-SF-7a)

    The PROMIS-Fatigue-SF-7a is a 7-question, 5-point scale used to assess fatigue.

    Measured: Baseline to end of Double-Blind Treatment Period (8 weeks)

  4. Change in severity of EDS as measured by the ESS

    The ESS is an 8-item, 4-point rating scale.

    Measured: Baseline through Week 1 and through Week 2 of Titration Period (1 week and 2 weeks)

  5. Onset of efficacy of HBS-301 compared with placebo in treating cataplexy measured by WRC in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening

    The WRC is the average number of cataplexy attacks per week.

    Measured: Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)

  6. Change in severity of EDS as measured by the Clinical Global Impression of Change (EDS)

    The Clinical Global Impression of Change (EDS) is a 7-point scale used to measure the improvement or worsening of the participant's EDS relative to a baseline.

    Measured: Baseline to end of Double-blind Treatment Period (8 weeks)

  7. Change in severity of EDS as measured by the Patient Global Impression of Severity (EDS)

    The Patient Global Impression of Severity (EDS) is a participant-reported assessment that gauges the severity of a participant's EDS symptoms.

    Measured: Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  8. Improvement in the severity of EDS as measured by the Patient Global Impression of Change (EDS)

    The Patient Global Impression of Change (EDS) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their EDS symptoms.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  9. Change in severity of cataplexy as measured by the Clinical Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening

    The Clinical Global Impression of Severity (Cataplexy) is a 3-item observer-rated scale used to track cataplexy symptom changes.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  10. Change in severity of cataplexy as measured by the Patient Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening

    The Patient Global Impression of Severity (Cataplexy) is a participant-reported assessment that gauges the severity of cataplexy symptoms.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  11. Improvement in severity of cataplexy as measured by the Patient Global Impression of Change (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening

    The Patient Global Impression of Change (Cataplexy) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their cataplexy symptoms.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  12. Change in severity of fatigue as measured by the Patient Global Impression of Severity (Fatigue)

    The Patient Global Impression of Severity (Fatigue) is a participant-reported assessment that gauges the severity of a participant's fatigue symptoms.

    Measured: Baseline to the end of Double-blind Treatment Period (8 weeks)

  13. Change in severity of fatigue as measured by the Patient Global Impression of Change (Fatigue)

    The Patient Global Impression of Change (Fatigue) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their fatigue symptoms.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  14. Change in severity of narcolepsy symptoms as measured by the Narcolepsy Severity Scale (for participants with NT1) or Narcolepsy Severity Scale-2 (for participants with NT2)

    The Narcolepsy Severity Scale is a 15-item participant-reported questionnaire that assesses the severity and consequences of narcolepsy symptoms.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  15. Change in cognitive complaints as measured by the British Columbia Cognitive Complaints Inventory

    The British Columbia Cognitive Complaints Inventory is a participant-reported, 6-item, 4-point scale that assesses perceived cognitive difficulties.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  16. Change in health-related quality of life as measured by the Short Form-36 physical and mental component summaries

    The Short Form-36 includes 36 questions across 8 health domains to measure a participant's functional health and well-being.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  17. Change in work productivity as measured by the Work Productivity and Activity Impairment: Narcolepsy work productivity loss score

    The Work Productivity and Activity Impairment: Narcolepsy questionnaire is a 6-item scale used to measure impairments over 7 days.

    Measured: Baseline to the end of the Double-blind Treatment Period (8 weeks)

  18. Incidence of treatment-emergent adverse events

    A treatment-emergent adverse event is any adverse event reported after the first dose of study drug and up to 30 days after final dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug and up to 30 days after final dose of study drug.

    Measured: Throughout study (16 months, including Open-label Extension)

  19. Evaluate the pharmacokinetic concentrations of pitolisant and major identified metabolites

    Pharmacokinetics is the study of how the body interacts with administered substances for the duration of exposure.

    Measured: Throughout study (16 weeks)

Timeline

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

  1. First posted30 Jun 2026
  2. Study start4 Jun 2026
  3. Primary completionOct 2027 (estimated)
  4. Study completionNov 2027 (estimated)

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07675135
Sponsor's protocol ID
HBS-301-CL-301
Other IDs
2025-523821-17-00, 2025
Status last verified
Aug 2026
First submitted
22 Jun 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HBS-301 in people with EDS and Cataplexy, run by Harmony Biosciences Management, Inc. at 53 sites in 2 countries.

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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michelle Manuel (847-903-4610, clinicaltrials@harmonybiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS) (time frame: Baseline to end of Double-Blind Treatment Period (8 weeks)). 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 NCT07675135.

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 27 Aug 2026.

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