Recruiting
Phase 3

HBS-301

Sponsor:

Harmony Biosciences Management, Inc.

Code:

NCT07675135

Conditions

EDS

Cataplexy

Fatigue

Narcolepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HBS-301

Placebo

Study Details

Brief 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.

Conditions

EDS

Cataplexy

Fatigue

Narcolepsy

Study ID

NCT07675135

Start date

Jun 4, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Double-Blind Treatment Period HBS-301

HBS-301 tablets administered once daily in the morning upon wakening

placebo comparator: Double-blind Treatment Period Placebo

Matching placebo tablets administered once daily in the morning upon wakening

experimental: Open-Label Extension Period HBS-301

HBS-301 tablets administered once daily in the morning upon wakening

Interventions

HBS-301

HBS-301 tablet

Placebo

Placebo tablet

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) ]

Central Contacts and Locations

Central contacts

Michelle Manuel

847-903-4610clinicaltrials@harmonybiosciences.com

Katie Wilmsen

443-309-5556clinicaltrials@harmonybiosciences.com

Locations

Phoenix Medical Group, PC

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Daniel Kasenovich

(623) 583-6542dkasenovich@phxresearch.com

Principal Investigator:

Robert Orr, DO

Santa Monica Clinical Trials

Recruiting

Los Angeles, California, United States, 90025

Contacts

Samantha Montanez

(310) 586-0843smontanez@smclinicaltrials.com

Principal Investigator:

Daniel Norman, MD

Stanford Center for Sleep Sciences and Medicine

Recruiting

Redwood City, California, United States, 94063

Contacts

Sara Lomba

(650) 799-1565slomba@stanford.edu

Principal Investigator:

Oliver Sum Ping, MD

Trial Site Solutions

Recruiting

San Ramon, California, United States, 94583

Contacts

Phil Strauss

(925) 415-5353phil@sleepmds.com

Principal Investigator:

Haramandeep Singh, MD

Alpine Clinical Research Center, Inc

Recruiting

Boulder, Colorado, United States, 80301

Contacts

Federica Bresciani

(601) 520-1333fika@alpineresearch.com

Principal Investigator:

John R Harsh, PhD

Delta Waves LLC

Recruiting

Colorado Springs, Colorado, United States, 80918

Contacts

Emma Gallagher

(719) 262-9283egallagher@deltawaves.org

Principal Investigator:

Jonathan Olin, MD

PharmaDev Clinical Research Institute, LLC

Recruiting

Miami, Florida, United States, 33176

Contacts

Rolando Rodriguez

(305) 420-5636rrodriguez@pharmadevresearch.com

Principal Investigator:

Edward Mezerhane, MD

Florida Pediatric Sleep Disorders Institute

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Heidi Patenaude

(407) 898-2767heidi@ajayihealthcare.com

Principal Investigator:

Akinyemi O Ajayi, MD

Neurotrials Research Inc

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Shriya Parekh

404-851-9934sparekh@neurotrials.com

Principal Investigator:

Dennis Lacey, MD

Sleep Practitioners, LLC

Recruiting

Macon, Georgia, United States, 31210

Contacts

Noelle Williams

(478) 745-5779nwilliams@sleeppractitioners.com

Principal Investigator:

Charles C Wells, Jr, MD

Southeast Lung Associates Research

Recruiting

Rincon, Georgia, United States, 31326

Contacts

Lisa Rodnicki

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

Principal Investigator:

Maria Mascolo, MD

Clinical Research Institute Stockbridge

Recruiting

Stockbridge, Georgia, United States, 30281

Contacts

Beverley Jenkins

(678) 782-5358bjenkins@clinicalresearchinstitute.us

Principal Investigator:

Phillip Nowlin, MD

Revive Research Institute, Inc

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Abhishek Dhillon

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

Principal Investigator:

Syed Raza, MD

Clinical Neurophysiology Services

Recruiting

Sterling Heights, Michigan, United States, 48314

Contacts

Jessica Austin

(586)-254-0707austinj@sleepandattentiondisorders.com

Principal Investigator:

Shaffi Kanjwal, MD

St. Lukes Sleep Medicine and Research Center

Recruiting

Chesterfield, Missouri, United States, 63017

Contacts

Kimberly Allen-Bowzer

(314) 205-6011SLHSleepResearch@stlukes-stl.com

Principal Investigator:

Michael McLeland, PhD

Clinical Research of Gastonia

Recruiting

Gastonia, North Carolina, United States, 28054

Contacts

Melissa Lanham

704-675-7144mlanham@crgastonia.com

Principal Investigator:

Anup Banerjee, MD

Stern Research Partners

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Felix Kurniawan

704-659-0090felix@arsmnc.com

Principal Investigator:

Thomas Stern, MD

Intrepid Research, LLC

Recruiting

Cincinnati, Ohio, United States, 45245

Contacts

Tiffany Schira

(513) 977-8891tschira@intrepidresearch.md

Principal Investigator:

Bruce C Corser, MD

Abington Neurological Associates

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Rachel Grossman

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

Principal Investigator:

John Khoury, MD

Berks Schuylkill Respiratory Specialists

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Contacts

Lisa Hill

(610) 685-5864lhill@lungmd.net

Principal Investigator:

Alec Platt, MD

Lowcountry Lung and Critical Care PA

Recruiting

Charleston, South Carolina, United States, 29406

Contacts

Courtney Arnold

(843) 572-8545carnold@lowcountrylung.com

Principal Investigator:

Thomas D Kaelin Jr, DO

Bogan Sleep Consultants, LLC

Recruiting

Columbia, South Carolina, United States, 29201

Contacts

Lorraine Potts

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

Principal Investigator:

Richard Bogan, MD

Aayus Research

Recruiting

Austin, Texas, United States, 78731

Contacts

Maria-Fernanda Gamero

(803) 606-2052Maria@aayus.co

Principal Investigator:

Bhavim Desai, MD

Southwest Family Medicine

Recruiting

Dallas, Texas, United States, 75235

Contacts

Safia Shaikh

(469) 893-1242sshaikh@swmedicalgroup.com

Principal Investigator:

Chrisette Dharma, MD

Sleep Therapy & Research Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Erin Marshall

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

Principal Investigator:

Nagwa Lamaie, MD

Tricoastal Narcolepsy and Sleep Disorders Center

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Natalia Dubock

(832) 210-3850research@tricoastalsleep.com

Principal Investigator:

Gerry Meskill, MD

Sleep and Performance Research Center

Recruiting

Spokane, Washington, United States, 99202

Contacts

Olivia Brooks

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

Principal Investigator:

Devon Hansen, PhD

AMNDX Inc

Recruiting

Markham, Ontario, Canada, M5S 3A3

Contacts

Urszula Lamoureux

416-435-6244urszula@amndx.ca

Principal Investigator:

Alan Lowe

Jodha Tishon Inc

Recruiting

Toronto, Ontario, Canada, M5S 3A3

Contacts

Naheed Hossain

(416) 551-8296naheedkhossain@jodhatishon.com

Principal Investigator:

Colin Shapiro

More Information

Sponsor

Harmony Biosciences Management, Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • pitolisant
  • HBS-301
  • narcolepsy
  • EDS
  • cataplexy
  • fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Harmony Biosciences Management, Inc. on 2026-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.