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Clinical Trials in the USA / NCT07500090
Recruiting Phase 3

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

NCT07500090 · tracked via the Priya Life Science USA tracker
Sponsor
Harmony Biosciences Management, Inc.
Phase
Phase 3
Started
2026-03-16
Last updated
2026-09-14

Condition(s) studied

Idiopathic Hypersomnia

Investigational drug(s) / intervention(s)

HBS-301 tabletPlacebo

HBS-301 tablet: HBS-301 tablet

Placebo: Placebo tablet

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Sleep Disorders Center of Alabama Birmingham Alabama Recruiting
Phoenix Medical Group LLC Peoria Arizona Recruiting
Stanford Center for Sleep Medicine Redwood City California Recruiting
Trial Site Solutions San Ramon California Recruiting
Santa Monica Clinical Trials Santa Monica California Recruiting
Alpine Clinical Research Center, Inc. Boulder Colorado Recruiting
Delta Waves LLC Colorado Springs Colorado Recruiting
PharmDev Research Institute, LLC Miami Florida Recruiting
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC) Winter Park Florida Recruiting
NeuroTrials Research Inc. Atlanta Georgia Recruiting
Sleep Practitioners, LLC Macon Georgia Recruiting
Southeast Lung Associates Research Rincon Georgia Recruiting
Clinical Research Institute Stockbridge Stockbridge Georgia Recruiting
Fort Wayne Neurological Center Fort Wayne Indiana Recruiting
Revive Research Institute Southfield Michigan Recruiting
Clinical Neuropsychology Services Sterling Heights Michigan Recruiting
St. Luke's Hospital, Sleep Medicine and Research Center Chesterfield Missouri Recruiting
Clinical Research of Gastonia Gastonia North Carolina Recruiting
Stern Research Partners, LLC Huntersville North Carolina Recruiting
David Kudrow, MD Morrisville North Carolina Recruiting
Neuroscience Research Center, LLC Canton Ohio Recruiting
Intrepid Research Cincinnati Ohio Recruiting
Neurology Care Ardmore Oklahoma Recruiting
Abington Neurological Associates Abington Pennsylvania Recruiting
Suburban Research Associates West Chester Pennsylvania Recruiting
Berks Schuylkill Respiratory Specialists Wyomissing Pennsylvania Recruiting
Infinity Medical Research Inc. East Providence Rhode Island Recruiting
Lowcountry Lung and Critical Care, PA Charleston South Carolina Recruiting
Bogan Sleep Consultants, LLC Columbia South Carolina Recruiting
K2 Medical Research Nashville Tennessee Recruiting
Aayus Research Austin Texas Recruiting
Southwest Family Medicine Associates Dallas Texas Recruiting
Metroplex Pulmonary and Sleep Center McKinney Texas Recruiting
Sleep Therapy and Research Center San Antonio Texas Recruiting
HAS Research San Antonio Texas Recruiting
Tricoastal Narcolepsy and Sleep Disorders Center Sugar Land Texas Recruiting
TPMG Clinical Research Williamsburg Virginia Recruiting
Washington State University Sleep and Performance Center Spokane Washington Recruiting
West Virginia University Morgantown West Virginia Recruiting
University of Washington Madison Wisconsin Recruiting

+ 2 more sites — see the full list on the official registry below.

More Harmony Biosciences Management, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07500090 on ClinicalTrials.gov ↗ ← All trials in the USA