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A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

NCT07500090 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2026-03-30

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 idiopathic hypersomnia (IH) symptoms, including excessive daytime sleepiness (EDS), sleep inertia, and fatigue in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

The primary objective of this study is to evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms.

Secondary objectives include evaluating the efficacy of HBS-301 compared with placebo in treating EDS, sleep inertia, and fatigue.

Conditions

  • Idiopathic Hypersomnia

Interventions

DRUG

HBS-301 tablet

HBS-301 tablet

DRUG

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
2026-03-16
Primary Completion
2027-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT07500090 on ClinicalTrials.gov