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NCT07500090PHASE3Recruiting

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

Harmony Biosciences Management, Inc.

Start Date

3/16/2026

Completion Date

10/1/2028

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).

Detailed Description

Approximately 248 participants are planned for randomization in 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 (OLE) Period (1 year), and 30 days of safety follow-up.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

DRUG

HBS-301 tablet

DRUG

Placebo

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Conditions

Idiopathic Hypersomnia

Locations

Sleep Disorders Center of Alabama

Birmingham, Alabama 35213

United States

Stanford Center for Sleep Medicine

Redwood City, California 94063

United States

Santa Monica Clinical Trials

Santa Monica, California 90404

United States

Alpine Clinical Research Center, Inc.

Boulder, Colorado 80301

United States

PharmDev Research Institute, LLC

Miami, Florida 33176

United States

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

Winter Park, Florida 32789

United States

NeuroTrials Research Inc.

Atlanta, Georgia 30328

United States

Sleep Practitioners, LLC

Macon, Georgia 31210

United States

Phillip Nowlin

Stockbridge, Georgia 30281

United States

Revive Research Institute

Southfield, Michigan 48975

United States

St. Luke's Hospital, Sleep Medicine and Research Center

Chesterfield, Missouri 63017

United States

Clinical Research of Gastonia

Gastonia, North Carolina 28054

United States

Stern Research Partners, LLC

Huntersville, North Carolina 28078

United States

David Kudrow, MD

Morrisville, North Carolina 27560

United States

Suburban Research Associates

West Chester, Pennsylvania 19380

United States

Respiratory Specialists

Wyomissing, Pennsylvania 19610

United States

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina 29406

United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina 29201

United States

K2 Medical Research

Nashville, Tennessee 37204

United States

Southwest Family Medicine Associates

Dallas, Texas 75235

United States

HAS Research

San Antonio, Texas 78240

United States

West Virginia University

Morgantown, West Virginia 26506

United States