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A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

Evaluating HBS-301's effects and safety in narcolepsy patients.

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18 years and older
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Phase 3

Narcolepsy is a condition that makes people feel very sleepy during the day. This study is testing a new medicine called HBS-301 to see if it helps with narcolepsy. The study is called a "Phase 3" study, which means it is in the later stages of testing. The study is "double-blind," meaning that neither the participants nor the doctors will know who is getting the real medicine or a placebo (a fake medicine that looks the same). This is done to make sure the results are fair.

The study will have different parts. First, there will be a Screening/Baseline Period that can last up to 28 days. Then, there is an 8-week treatment period where participants will take the medicine. After that, there is an optional 1-year extension where everyone can take the real medicine, and a final check-up 30 days later.

  • The study will last for over a year if you join the extension.
  • You will need to stop certain other medicines during the study.
  • It's important to have stable health conditions to join.
Study details
    EDS
    Cataplexy
    Fatigue
    Narcolepsy

NCT07675135

Harmony Biosciences Management, Inc.

17 October 2026

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

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

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

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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