HBS-301 for Idiopathic Hypersomnia

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

Recruiting Phase 3 Interventional Study
Idiopathic Hypersomnia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
248 (estimated)
Sponsor
Harmony Biosciences Management, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with idiopathic hypersomnia who experience excessive daytime sleepiness. Participants will take part in testing a treatment called HBS-301 and will be monitored for its effects on their symptoms.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a diagnosed case of idiopathic hypersomnia.
  • I experience excessive daytime sleepiness.
  • I have moderate to very severe symptoms of idiopathic hypersomnia.
  • I have been stable on my current medications for at least 3 months.

You may not be able to join if

  • I have hypersomnia caused by another medical disorder.
  • I have used pitolisant recently.
  • I have a psychiatric illness that is not well controlled.
  • I have a history of severe liver problems.
  • My kidney function is significantly impaired.
  • I have long QT syndrome or serious heart rhythm issues.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About 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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Trial Locations
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Eligibility Criteria
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 …
Contacts

Katie Wilmsen

443-309-5556

clinicaltrials@harmonybiosciences.com

CONTACT

Michelle Manuel

847-903-4610

clinicaltrials@harmonybiosciences.com

CONTACT