Recruiting
Phase 3

HBS-301

Sponsor:

Harmony Biosciences Management, Inc.

Code:

NCT07500090

Conditions

Idiopathic Hypersomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HBS-301 tablet

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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Conditions

Idiopathic Hypersomnia

Study ID

NCT07500090

Start date

Mar 16, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2028

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 IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.
  • Has EDS.
  • Has moderate to very severe symptoms of IH.
  • 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 use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis 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.
  • Has a history of moderate or severe hepatic impairment.
  • Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
  • Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).

Study Design

Enrollment

248 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 tablet

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 the end of the Double-blind Treatment Period (8 weeks) ]

Central Contacts and Locations

Central contacts

Katie Wilmsen

443-309-5556clinicaltrials@harmonybiosciences.com

Michelle Manuel

847-903-4610clinicaltrials@harmonybiosciences.com

Locations

Sleep Disorders Center of Alabama

Recruiting

Birmingham, Alabama, United States, 35213

Contacts

Joseph Wright

205-599-1020jwright@sleepalabama.com

Principal Investigator:

Robert Doekel

Phoenix Medical Group LLC

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Daniel Kasenovich

623-583-6542dkasenovich@phxresearch.com

Principal Investigator:

Robert Orr

Stanford Center for Sleep 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, 04583

Contacts

Phil Strauss

925-415-5353phil@sleepmds.com

Principal Investigator:

Haramandeep Singh

Santa Monica Clinical Trials

Recruiting

Santa Monica, California, United States, 90404

Contacts

Samantha Montanez

310-586-0843smontanez@smclinicaltrials.com

Principal Investigator:

Daniel Norman, MD

Alpine Clinical Research Center, Inc.

Recruiting

Boulder, Colorado, United States, 80301

Contacts

Frederica Bresciani

601-520-1333fika@alpineresearch.com

Principal Investigator:

John Harsh

Delta Waves LLC

Recruiting

Colorado Springs, Colorado, United States, 80918

Contacts

Emma Gallagher

719-262-9283egallagher@deltawaves.org

Principal Investigator:

Jonathan Olin

PharmDev Research Institute, LLC

Recruiting

Miami, Florida, United States, 33176

Contacts

Rolando Rodriguez

305-420-5636rrodriguez@pharmadevresearch.com

Principal Investigator:

Edward Mezerhane, MD

Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Heidi Patenube

407-898-2767heidi@ajayhealthcare.com

Principal Investigator:

Akinyemi Ajayi

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 Wells

Southeast Lung Associates Research

Recruiting

Rincon, Georgia, United States, 31326

Contacts

Lisa Rodnicki

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

Principal Investigator:

Maria Mascolo

Clinical Research Institute Stockbridge

Recruiting

Stockbridge, Georgia, United States, 30281

Contacts

Beverly Jenkins

678-782-5358bjenkins@clinicalresearchinstitute.us

Principal Investigator:

Phillip Nowlin

Fort Wayne Neurological Center

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Patti Case

704-659-0090pcase@iuhealth.org

Principal Investigator:

James Stevens

Revive Research Institute

Recruiting

Southfield, Michigan, United States, 48975

Contacts

Abhishek Dhillon

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

Principal Investigator:

Syed Muhammad Talib Rizvi Raza, MD

Clinical Neuropsychology Services

Recruiting

Sterling Heights, Michigan, United States, 48314

Contacts

Jessica Austin

586-254-0707austinj@sleepandattentiondisorders.com

Principal Investigator:

Shaffi Kanjwal

St. Luke's Hospital, 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

Madeline Gibson

704-675-7144mgibson@crgastonia.com

Principal Investigator:

Anup Banerjee, MD

Stern Research Partners, LLC

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Felix Kurniawan

704-659-0090felix@arsmnc.com

Principal Investigator:

Thomas Stern, MD

David Kudrow, MD

Recruiting

Morrisville, North Carolina, United States, 27560

Contacts

Victoria Taylor

984-377-3737HarmonyIHPEC@science37.com

Principal Investigator:

David Kudrow

Neuroscience Research Center, LLC

Recruiting

Canton, Ohio, United States, 44718

Contacts

Kellie McCabe

330-244-2542kelliem@neurocarecenter.com

Principal Investigator:

Ryan Drake

Intrepid Research

Recruiting

Cincinnati, Ohio, United States, 45245

Contacts

Tiffany Schira

513-977-8891tschira@intrepidresearch.md

Principal Investigator:

Bruce Corser

Neurology Care

Recruiting

Ardmore, Oklahoma, United States, 73401

Contacts

Maaz Ghani

mghani@sunbeamresearch.com

Principal Investigator:

Baha Abu-Esheh

Abington Neurological Associates

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Rachel Grossman

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

Principal Investigator:

John Khoury

Suburban Research Associates

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

Carol McDevitt

610-891-9024cmcdevitt@suburbanresearch.com

Principal Investigator:

Omer Abdullah, MD

Berks Schuylkill Respiratory Specialists

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Contacts

Lisa Hill

610-685-5864lhill@lungmd.net

Principal Investigator:

Alec Platt, MD

Infinity Medical Research Inc.

Recruiting

East Providence, Rhode Island, United States, 02914

Contacts

Patricia Mello

508-998-3041pmello@infinitymedicalresearch.com

Principal Investigator:

Curtis Mello

Lowcountry Lung and Critical Care, PA

Recruiting

Charleston, South Carolina, United States, 29406

Contacts

Courtney Arnold

843-572-8545carnold@lowcountrylung.com

Principal Investigator:

Thomas Kaelin

Bogan Sleep Consultants, LLC

Recruiting

Columbia, South Carolina, United States, 29201

Contacts

Lorraine Potts

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

Principal Investigator:

Richard Bogan

K2 Medical Research

Recruiting

Nashville, Tennessee, United States, 37204

Contacts

Francesca McKay

615-208-5252francesca.mckay@k2med.com

Principal Investigator:

Joshua Lennon, MD

Aayus Research

Recruiting

Austin, Texas, United States, 78731

Contacts

Maria-Fernanda Gamero

803-606-2052Maria@aayus.com

Principal Investigator:

Bhavim Desai

Southwest Family Medicine Associates

Recruiting

Dallas, Texas, United States, 75235

Contacts

Safia Shaikh

493-893-1242sshaikh@swmedicalgroup.com

Principal Investigator:

Chrisette Dharma

Metroplex Pulmonary and Sleep Center

Recruiting

McKinney, Texas, United States, 75069

Contacts

Rupa Krishna

972-838-1892rkrishna@mpsleepcenter.com

Principal Investigator:

Shahrukh Kureishy

Sleep Therapy and Research Center

Recruiting

San Antonio, Texas, United States, 30328

Contacts

Erin Marshall

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

Principal Investigator:

Nagwa Lamaie

HAS Research

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Kimberly Rosales

210-614-7711kimberly.rosales@hasresearch.com

Principal Investigator:

Hernan A Salazar, DO

Tricoastal Narcolepsy and Sleep Disorders Center

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Natalia Dubok

832-210-3850research@tricoastalsleep.com

Principal Investigator:

Gerry Meskill

TPMG Clinical Research

Recruiting

Williamsburg, Virginia, United States, 23188

Contacts

Gabrielle Land

757-707-3503gabrielle.land@tpmgpc.com

Principal Investigator:

Richard Parisi

Washington State University Sleep and Performance Center

Recruiting

Spokane, Washington, United States, 99210

Contacts

Olivia Brooks

509-358-7754Olivia.brooks@wsu.edu

Principal Investigator:

Devon Hansen

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Lauren Chase

304-598-4000

Principal Investigator:

Mouhannad Azzouz

University of Washington

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Ahmad Allen

608-232-3333aallen45@wisc.edu

Principal Investigator:

David Plante

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) 551-8296aheedkhossain@jodhatishon.com

Principal Investigator:

Colin Shapiro

More Information

Sponsor

Harmony Biosciences Management, Inc.

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • pitolisant
  • HBS-301
  • idiopathic hypersomnia
  • excessive daytime sleepiness
  • sleep inertia
  • fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Harmony Biosciences Management, Inc. on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.