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

Studying HBS-301's effects on idiopathic hypersomnia symptoms.

Recruiting
18 years and older
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Phase 3

This study is testing a medicine called HBS-301 for adults with idiopathic hypersomnia (IH), a condition that makes people unusually sleepy during the day. The study is randomized, meaning participants are chosen by chance to receive either the real medicine or a placebo (a fake treatment) without knowing which one they're getting. It has several stages, starting with a screening period of up to 28 days to see if you qualify, followed by 8 weeks of treatment, and an optional year-long period where everyone gets the real medicine. After that, there's a 30-day check-up to make sure the medicine is safe.

  • Study lasts up to more than a year including all periods.
  • Participants will have regular visits and treatments.
  • Some people might get a placebo during the first 8 weeks.
Study details
    Idiopathic Hypersomnia

NCT07500090

Harmony Biosciences Management, Inc.

17 October 2026

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