A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
Recruiting
Phase 3Interventional 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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).
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.