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

NCT07675135 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HBS-301

HBS-301 tablet

OTHER

Placebo

Placebo tablet

Sponsors & Collaborators

  • Harmony Biosciences Management, Inc.

    lead INDUSTRY

Principal Investigators

  • David Seiden, MD · Harmony Biosciences Management, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-04
Primary Completion
2027-10-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675135 on ClinicalTrials.gov