Image

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

Testing HBS-301 for safety and effectiveness in people with Idiopathic Hypersomnia.

Recruiting
18 years and older
All
Phase 3

This study looks at how well and safely a medicine called HBS-301 helps adults (18 years or older) with idiopathic hypersomnia (IH), a condition causing too much daytime sleepiness, trouble waking up, and tiredness. In this study, HBS-301 will be compared to a placebo (a substance with no actual medicine) to see if it works better at treating these symptoms.

Before participants start, they must have a confirmed IH diagnosis. During the study, they will be in a randomized (assigned by chance), double-blind (neither participants nor researchers know who gets the medicine or placebo), placebo-controlled setup.

  • Study Length: Screening/Baseline (up to 28 days), Treatment (8 weeks), optional Extension (1 year).
  • Participants: About 248 adults with IH.
  • Visits: Regular visits during the study, including follow-ups.

To join, participants need stable medication use and, if they have conditions like sleep apnea, must use treatments consistently. People with sleepiness due to other medical issues or certain health problems cannot join.

Study details
    Idiopathic Hypersomnia

NCT07500090

Harmony Biosciences Management, Inc.

9 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race
Ethnicity
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.