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NCT07675135PHASE3Recruiting

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

Harmony Biosciences Management, Inc.

Start Date

6/4/2026

Completion Date

11/1/2027

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.

Detailed 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 EDS, cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy. Approximately 258 participants are planned for randomization into 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 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 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).

Interventions

DRUG

HBS-301

OTHER

Placebo

Interested in This Trial?

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Conditions

EDSCataplexyFatigueNarcolepsy

Locations

Sleep Disorders Center of Alabama

Birmingham, Alabama 35213

United States

Springhill Medical Center

Mobile, Alabama 36608

United States

Phoenix Medical Group, PC

Peoria, Arizona 85381

United States

West Coast Pulmonary & Sleep Disorders Center

Lancaster, California 93534

United States

Santa Monica Clinical Trials

Los Angeles, California 90025

United States

Stanford Center for Sleep Sciences and Medicine

Redwood City, California 94063

United States

University of California San Francisco

San Francisco, California 94107

United States

Trial Site Solutions

San Ramon, California 94583

United States

Alpine Clinical Research Center, Inc

Boulder, Colorado 80301

United States

Delta Waves LLC

Colorado Springs, Colorado 80918

United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida 33176

United States

Florida Pediatric Sleep Disorders Institute

Winter Park, Florida 32789

United States

Neurotrials Research Inc

Atlanta, Georgia 30328

United States

Sleep Practitioners, LLC

Macon, Georgia 31210

United States

Southeast Lung Associates Research

Rincon, Georgia 31326

United States

Clinical Research Institute Stockbridge

Stockbridge, Georgia 30281

United States

NorthShore University HealthSystem

Glenview, Illinois 60026

United States

OSF St Francis Medical Center

Peoria, Illinois 61606

United States

Fort Wayne Neurological Center

Fort Wayne, Indiana 46804

United States

University of Kansas Hospital Main Campus

Kansas City, Kansas 66160

United States

Henry Ford Medical Center

Novi, Michigan 48377

United States

Revive Research Institute, Inc

Southfield, Michigan 48075

United States

Clinical Neurophysiology Services

Sterling Heights, Michigan 48314

United States

St. Lukes Sleep Medicine and Research Center

Chesterfield, Missouri 63017

United States

Patient First MD

Middletown, New Jersey 07748

United States

Northwell Health Physician Partners

New Hyde Park, New York 11042

United States

Research Carolina Elite LLC

Denver, North Carolina 28037

United States

Clinical Research of Gastonia

Gastonia, North Carolina 28054

United States

Stern Research Partners

Huntersville, North Carolina 28078

United States

Intrepid Research, LLC

Cincinnati, Ohio 45245

United States

The Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Neurology Care

Ardmore, Oklahoma 73401

United States

Abington Neurological Associates

Abington, Pennsylvania 19001

United States

Geisinger Medical Center

Danville, Pennsylvania 17821

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States

Berks Schuylkill Respiratory Specialists

Wyomissing, Pennsylvania 19610

United States

Infinity Medical Research Inc

East Providence, Rhode Island 02914

United States

Lowcountry Lung and Critical Care PA

Charleston, South Carolina 29406

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina 29201

United States

K2 Medical Research - Nashville

Nashville, Tennessee 37204

United States

Aayus Research

Austin, Texas 78731

United States

Southwest Family Medicine

Dallas, Texas 75235

United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas 75069

United States

Sleep Therapy & Research Center

San Antonio, Texas 78229

United States

HasResearch

San Antonio, Texas 78240

United States

Tricoastal Narcolepsy and Sleep Disorders Center

Sugar Land, Texas 77478

United States

TPMG Clinical Research

Williamsburg, Virginia 23188

United States

Sleep and Performance Research Center

Spokane, Washington 99202

United States

West Virginia University Hospital

Morgantown, West Virginia 26506

United States

University of Wisconsin-Madison

Madison, Wisconsin 53719

United States

AMNDX Inc

Markham, Ontario M5S 3A3

Canada

Jodha Tishon Inc

Toronto, Ontario M5S 3A3

Canada