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 Jul 21, 2026, 4:39 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

Study identification

NCT ID: NCT07675135
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Harmony Biosciences Management, Inc.; Industry
Enrollment: 258 participants

Conditions and interventions

Conditions

Interventions

HBS-301 Drug
Placebo Other

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: Jun 29, 2026

2026 – 2027

United States locations

U.S. sites: 14
U.S. states: 10
U.S. cities: 14

Facility	City	State	ZIP	Site status
Phoenix Medical Group, PC	Peoria	Arizona	85381	Recruiting
Santa Monica Clinical Trials	Los Angeles	California	90025	Recruiting
Alpine Clinical Research Center, Inc	Boulder	Colorado	80301	Recruiting
PharmaDev Clinical Research Institute, LLC	Miami	Florida	33176	Recruiting
Central Florida Pediatric Sleep Disorders Institute	Winter Park	Florida	32789	Recruiting
Neurotrials Research Inc	Atlanta	Georgia	30328	Recruiting
Sleep Practitioners, LLC	Macon	Georgia	31210	Recruiting
Intrepid Research, LLC	Cincinnati	Ohio	45245	Recruiting
Respiratory Specialists	Wyomissing	Pennsylvania	19610	Recruiting
Lowcountry Lung and Critical Care PA	Charleston	South Carolina	29406	Recruiting
Bogan Sleep Consultants, LLC	Columbia	South Carolina	29201	Recruiting
Southwest Family Medicine	Dallas	Texas	75235	Recruiting
Sleep Therapy & Research Center	San Antonio	Texas	78229	Recruiting
Sleep and Performance Research Center	Spokane	Washington	99202	Recruiting

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

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 Jun 29, 2026 · Synced Jul 21, 2026

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

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