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

Recruiting at 11 trial locations

Overseen By Michelle Manuel

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Harmony Biosciences Management, Inc.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

248 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

David Seiden, MD

Principal Investigator

Harmony Biosciences Management, Inc.

Are You a Good Fit for This Trial?

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, an actigraphy report with sleep log on file that led to the diagnosis and was completed within the last 10 years.

* Has moderate to very severe symptoms of IH.

* If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants, 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. 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.

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Open-label Extension Period HBS-301 Experimental Treatment 1 Intervention

HBS-301 tablets administered once daily in the morning upon wakening at least 1 hour before meals

Group II: Double-Blind Treatment Period HBS-301 Experimental Treatment 1 Intervention

HBS-301 tablets administered once daily in the morning upon wakening at least 1 hour before meals

Group III: Double-blind Treatment Period Placebo Placebo Group 1 Intervention

Matching placebo tablets administered once daily in the morning upon wakening at least 1 hour before meals

Who Is Running the Clinical Trial?

Harmony Biosciences Management, Inc.

Lead Sponsor

Trials

9

Recruited

2,000+