RecruitingPhase 3NCT07675135

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

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension

Sponsor

Harmony Biosciences Management, Inc.

Enrollment

258 participants

Start Date

Jun 4, 2026

Study Type

INTERVENTIONAL

Conditions

Fatigue Narcolepsy EDS Cataplexy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HBS-301 and Placebo for people with cataplexy, eds, and other related conditions. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHBS-301

HBS-301 tablet

OTHERPlacebo

Placebo tablet

Locations(53)

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

View Full Details on ClinicalTrials.gov

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NCT07675135

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