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

Harmony Biosciences Management, Inc.

Status and phase: Enrolling; Phase 3

Conditions: Idiopathic Hypersomnia

Treatments: Drug: HBS-301 tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07500090

2025-523822-42-00 (EU Trial (CTIS) Number)

HBS-301-CL-302

Details and patient eligibility

About

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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Full description

Approximately 248 participants are planned for randomization in the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension (OLE) Period (1 year), and 30 days of safety follow-up.

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.
• Has EDS.
• Has moderate to very severe symptoms of IH.
• If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As-needed use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis is not permitted.

Exclusion criteria

• Has hypersomnia due to another medical disorder.
• Has a history of pitolisant use within 5 half-lives prior to Screening.
• Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled.
• Has a history of moderate or severe hepatic impairment.
• Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
• Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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248 participants in 3 patient groups, including a placebo group

Double-Blind Treatment Period HBS-301

Experimental group

Description:

HBS-301 tablets administered once daily in the morning upon wakening

Treatment:

Drug: HBS-301 tablet

Double-blind Treatment Period Placebo

Placebo Comparator group

Description:

Matching placebo tablets administered once daily in the morning upon wakening

Treatment:

Drug: Placebo

Open-label Extension Period HBS-301

Experimental group

Description:

HBS-301 tablets administered once daily in the morning upon wakening

Treatment:

Drug: HBS-301 tablet