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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07675135

Public ClinicalTrials.gov record NCT07675135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07675135
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
258 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 3, 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027
Last update posted
Aug 26, 2026

2026 – 2027

United States locations

U.S. sites
51
U.S. states
25
U.S. cities
49
Facility City State ZIP Site status
Sleep Disorders Center of Alabama Birmingham Alabama 35213 Not yet recruiting
Springhill Medical Center Mobile Alabama 36608 Not yet recruiting
Phoenix Medical Group, PC Peoria Arizona 85381 Recruiting
West Coast Pulmonary & Sleep Disorders Center Lancaster California 93534 Not yet recruiting
Santa Monica Clinical Trials Los Angeles California 90025 Recruiting
Stanford Center for Sleep Sciences and Medicine Redwood City California 94063 Recruiting
University of California San Francisco San Francisco California 94107 Not yet recruiting
Trial Site Solutions San Ramon California 94583 Recruiting
Alpine Clinical Research Center, Inc Boulder Colorado 80301 Recruiting
Delta Waves LLC Colorado Springs Colorado 80918 Recruiting
PharmaDev Clinical Research Institute, LLC Miami Florida 33176 Recruiting
Florida Pediatric Sleep Disorders Institute Winter Park Florida 32789 Recruiting
Neurotrials Research Inc Atlanta Georgia 30328 Recruiting
Sleep Practitioners, LLC Macon Georgia 31210 Recruiting
Southeast Lung Associates Research Rincon Georgia 31326 Recruiting
Clinical Research Institute Stockbridge Stockbridge Georgia 30281 Recruiting
NorthShore University HealthSystem Glenview Illinois 60026 Not yet recruiting
OSF St Francis Medical Center Peoria Illinois 61606 Not yet recruiting
Fort Wayne Neurological Center Fort Wayne Indiana 46804 Not yet recruiting
University of Kansas Hospital Main Campus Kansas City Kansas 66160 Not yet recruiting
Henry Ford Medical Center Novi Michigan 48377 Not yet recruiting
Revive Research Institute, Inc Southfield Michigan 48075 Recruiting
Clinical Neurophysiology Services Sterling Heights Michigan 48314 Recruiting
St. Lukes Sleep Medicine and Research Center Chesterfield Missouri 63017 Recruiting
Patient First MD Middletown New Jersey 07748 Not yet recruiting
Northwell Health Physician Partners New Hyde Park New York 11042 Not yet recruiting
Research Carolina Elite LLC Denver North Carolina 28037 Not yet recruiting
Clinical Research of Gastonia Gastonia North Carolina 28054 Recruiting
Stern Research Partners Huntersville North Carolina 28078 Recruiting
Intrepid Research, LLC Cincinnati Ohio 45245 Recruiting
The Cleveland Clinic Foundation Cleveland Ohio 44195 Not yet recruiting
Neurology Care Ardmore Oklahoma 73401 Not yet recruiting
Abington Neurological Associates Abington Pennsylvania 19001 Recruiting
Geisinger Medical Center Danville Pennsylvania 17821 Not yet recruiting
University of Pittsburgh Pittsburgh Pennsylvania 15213 Not yet recruiting
Berks Schuylkill Respiratory Specialists Wyomissing Pennsylvania 19610 Recruiting
Infinity Medical Research Inc East Providence Rhode Island 02914 Not yet recruiting
Lowcountry Lung and Critical Care PA Charleston South Carolina 29406 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Not yet recruiting
Bogan Sleep Consultants, LLC Columbia South Carolina 29201 Recruiting
K2 Medical Research - Nashville Nashville Tennessee 37204 Not yet recruiting
Aayus Research Austin Texas 78731 Recruiting
Southwest Family Medicine Dallas Texas 75235 Recruiting
Metroplex Pulmonary and Sleep Center McKinney Texas 75069 Not yet recruiting
Sleep Therapy & Research Center San Antonio Texas 78229 Recruiting
HasResearch San Antonio Texas 78240 Not yet recruiting
Tricoastal Narcolepsy and Sleep Disorders Center Sugar Land Texas 77478 Recruiting
TPMG Clinical Research Williamsburg Virginia 23188 Not yet recruiting
Sleep and Performance Research Center Spokane Washington 99202 Recruiting
West Virginia University Hospital Morgantown West Virginia 26506 Not yet recruiting
University of Wisconsin-Madison Madison Wisconsin 53719 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07675135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 26, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07675135 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →