RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Harmony Biosciences Management, Inc. • ClinicalTrials.gov ID: NCT07675135

Registry updated: 2026-08-27

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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 excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Interventions

HBS-301 (Drug)
HBS-301 tablet
Placebo (Other)
Placebo tablet

Eligibility criteria

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).

Conditions

EDS Cataplexy Fatigue Narcolepsy

Locations

Sleep Disorders Center of Alabama — Birmingham, Alabama, United States
Springhill Medical Center — Mobile, Alabama, United States
Phoenix Medical Group, PC — Peoria, Arizona, United States
West Coast Pulmonary & Sleep Disorders Center — Lancaster, California, United States
Santa Monica Clinical Trials — Los Angeles, California, United States
Stanford Center for Sleep Sciences and Medicine — Redwood City, California, United States
University of California San Francisco — San Francisco, California, United States
Trial Site Solutions — San Ramon, California, United States
Alpine Clinical Research Center, Inc — Boulder, Colorado, United States
Delta Waves LLC — Colorado Springs, Colorado, United States
PharmaDev Clinical Research Institute, LLC — Miami, Florida, United States
Florida Pediatric Sleep Disorders Institute — Winter Park, Florida, United States
Neurotrials Research Inc — Atlanta, Georgia, United States
Sleep Practitioners, LLC — Macon, Georgia, United States
Southeast Lung Associates Research — Rincon, Georgia, United States
Clinical Research Institute Stockbridge — Stockbridge, Georgia, United States
NorthShore University HealthSystem — Glenview, Illinois, United States
OSF St Francis Medical Center — Peoria, Illinois, United States
Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
University of Kansas Hospital Main Campus — Kansas City, Kansas, United States
Henry Ford Medical Center — Novi, Michigan, United States
Revive Research Institute, Inc — Southfield, Michigan, United States
Clinical Neurophysiology Services — Sterling Heights, Michigan, United States
St. Lukes Sleep Medicine and Research Center — Chesterfield, Missouri, United States
Patient First MD — Middletown, New Jersey, United States
Northwell Health Physician Partners — New Hyde Park, New York, United States
Research Carolina Elite LLC — Denver, North Carolina, United States
Clinical Research of Gastonia — Gastonia, North Carolina, United States
Stern Research Partners — Huntersville, North Carolina, United States
Intrepid Research, LLC — Cincinnati, Ohio, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Neurology Care — Ardmore, Oklahoma, United States
Abington Neurological Associates — Abington, Pennsylvania, United States
Geisinger Medical Center — Danville, Pennsylvania, United States
University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Berks Schuylkill Respiratory Specialists — Wyomissing, Pennsylvania, United States
Infinity Medical Research Inc — East Providence, Rhode Island, United States
Lowcountry Lung and Critical Care PA — Charleston, South Carolina, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States
K2 Medical Research - Nashville — Nashville, Tennessee, United States
Aayus Research — Austin, Texas, United States
Southwest Family Medicine — Dallas, Texas, United States
Metroplex Pulmonary and Sleep Center — McKinney, Texas, United States
Sleep Therapy & Research Center — San Antonio, Texas, United States
HasResearch — San Antonio, Texas, United States
Tricoastal Narcolepsy and Sleep Disorders Center — Sugar Land, Texas, United States
TPMG Clinical Research — Williamsburg, Virginia, United States
Sleep and Performance Research Center — Spokane, Washington, United States
West Virginia University Hospital — Morgantown, West Virginia, United States
University of Wisconsin-Madison — Madison, Wisconsin, United States
AMNDX Inc — Markham, Ontario, Canada
Jodha Tishon Inc — Toronto, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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