New pill aims to tame Narcolepsy's sleep attacks and sudden muscle weakness

NCT ID NCT07675135

Recruiting now Disease control Sponsor: Harmony Biosciences Management, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 30, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study tests whether HBS-301 (pitolisant) can reduce excessive daytime sleepiness and cataplexy (sudden muscle weakness) in adults with narcolepsy. Participants receive either the drug or a placebo for several weeks, followed by an open-label phase where everyone gets the drug. The goal is to see if HBS-301 improves wakefulness and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: HBS-301 (pitolisant delayed-release)
What this could lead to: If successful, HBS-301 could offer a new treatment option to reduce daytime sleepiness and cataplexy attacks in people with narcolepsy.
What could go wrong: This is a phase 3 trial, but results may not confirm benefit over placebo. Side effects or lack of effectiveness could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Cataplexy Ehlers-Danlos syndrome Fatigue narcolepsy narcolepsy 1 narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CATAPLEXY EDS FATIGUE NARCOLEPSY

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••
Contact

Email: •••••@•••••

Locations

Aayus Research
RECRUITING

Austin, Texas, 78731, United States
Abington Neurological Associates
RECRUITING

Abington, Pennsylvania, 19001, United States
Alpine Clinical Research Center, Inc
RECRUITING

Boulder, Colorado, 80301, United States
Berks Schuylkill Respiratory Specialists
RECRUITING

Wyomissing, Pennsylvania, 19610, United States
Bogan Sleep Consultants, LLC
RECRUITING

Columbia, South Carolina, 29201, United States
Clinical Neurophysiology Services
RECRUITING

Sterling Heights, Michigan, 48314, United States
Clinical Research Institute Stockbridge
RECRUITING

Stockbridge, Georgia, 30281, United States
Clinical Research of Gastonia
RECRUITING

Gastonia, North Carolina, 28054, United States
Delta Waves LLC
RECRUITING

Colorado Springs, Colorado, 80918, United States
Florida Pediatric Sleep Disorders Institute
RECRUITING

Winter Park, Florida, 32789, United States
Fort Wayne Neurological Center
NOT_YET_RECRUITING

Fort Wayne, Indiana, 46804, United States
Geisinger Medical Center
NOT_YET_RECRUITING

Danville, Pennsylvania, 17821, United States
HasResearch
NOT_YET_RECRUITING

San Antonio, Texas, 78240, United States
Henry Ford Medical Center
NOT_YET_RECRUITING

Novi, Michigan, 48377, United States
Infinity Medical Research Inc
NOT_YET_RECRUITING

East Providence, Rhode Island, 02914, United States
Intrepid Research, LLC
RECRUITING

Cincinnati, Ohio, 45245, United States
K2 Medical Research - Nashville
NOT_YET_RECRUITING

Nashville, Tennessee, 37204, United States
Lowcountry Lung and Critical Care PA
RECRUITING

Charleston, South Carolina, 29406, United States
Medical University of South Carolina
NOT_YET_RECRUITING

Charleston, South Carolina, 29425, United States
Neurology Care
NOT_YET_RECRUITING

Ardmore, Oklahoma, 73401, United States
Neurotrials Research Inc
RECRUITING

Atlanta, Georgia, 30328, United States
NorthShore University HealthSystem
NOT_YET_RECRUITING

Glenview, Illinois, 60026, United States
Northwell Health Physician Partners
NOT_YET_RECRUITING

New Hyde Park, New York, 11042, United States
OSF St Francis Medical Center
NOT_YET_RECRUITING

Peoria, Illinois, 61606, United States
Patient First MD
NOT_YET_RECRUITING

Middletown, New Jersey, 07748, United States
PharmaDev Clinical Research Institute, LLC
RECRUITING

Miami, Florida, 33176, United States
Phoenix Medical Group, PC
RECRUITING

Peoria, Arizona, 85381, United States
Research Carolina Elite LLC
NOT_YET_RECRUITING

Denver, North Carolina, 28037, United States
Revive Research Institute, Inc
RECRUITING

Southfield, Michigan, 48075, United States
Santa Monica Clinical Trials
RECRUITING

Los Angeles, California, 90025, United States
Sleep Disorders Center of Alabama
NOT_YET_RECRUITING

Birmingham, Alabama, 35213, United States
Sleep Practitioners, LLC
RECRUITING

Macon, Georgia, 31210, United States
Sleep Therapy & Research Center
RECRUITING

San Antonio, Texas, 78229, United States
Sleep and Performance Research Center
RECRUITING

Spokane, Washington, 99202, United States
Southeast Lung Associates Research
RECRUITING

Rincon, Georgia, 31326, United States
Southwest Family Medicine
RECRUITING

Dallas, Texas, 75235, United States
Springhill Medical Center
NOT_YET_RECRUITING

Mobile, Alabama, 36608, United States
St. Lukes Sleep Medicine and Research Center
RECRUITING

Chesterfield, Missouri, 63017, United States

Contact Email: •••••@•••••
Stanford Center for Sleep Sciences and Medicine
RECRUITING

Redwood City, California, 94063, United States
Stern Research Partners
RECRUITING

Huntersville, North Carolina, 28078, United States
TPMG Clinical Research
NOT_YET_RECRUITING

Williamsburg, Virginia, 23188, United States
The Cleveland Clinic Foundation
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Trial Site Solutions
RECRUITING

San Ramon, California, 94583, United States
Tricoastal Narcolepsy and Sleep Disorders Center
RECRUITING

Sugar Land, Texas, 77478, United States

Contact Email: •••••@•••••
University of California San Francisco
NOT_YET_RECRUITING

San Francisco, California, 94107, United States
University of Kansas Hospital Main Campus
NOT_YET_RECRUITING

Kansas City, Kansas, 66160, United States
University of Pittsburgh
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of Wisconsin-Madison
NOT_YET_RECRUITING

Madison, Wisconsin, 53719, United States
West Coast Pulmonary & Sleep Disorders Center
NOT_YET_RECRUITING

Lancaster, California, 93534, United States
West Virginia University Hospital
NOT_YET_RECRUITING

Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.