HomeTrialNCT07500090
🔬NCT07500090Phase 3RECRUITING

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

Study Summary

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 treating idiopathic hypersomnia (IH) symptoms, including excessive daytime sleepiness (EDS), sleep inertia, and fatigue in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH). The primary objective of this study is to evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms. Secondary objectives include evaluating the efficacy of HBS-301 compared with placebo in treating EDS, sleep inertia, and fatigue.

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment248 participants
Primary Completion
Lead SponsorHarmony Biosciences Management, Inc.
Data Retrieved2026-04-11 04:15:56.573684+00:00
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