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Clinical Trials in the EU / 2025-523822-42-00
Authorised, not yet recruiting Phase III

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Idiopathic Hypersomnia (IH) Followed by an Open-label Extension

2025-523822-42-00 · tracked via the Priya Life Science EU tracker
Sponsor
Harmony Biosciences Management Inc
Sponsor type
Pharmaceutical company
Therapeutic area
Nervous System Diseases
Decision date
06/10/2026
Enrollment target
96
Sites
France, Germany, Belgium, Spain, Italy, Poland

Condition studied

Idiopathic hypersomnia (IH)

Investigational medicinal product(s)

Pitolisant"Placebo will be provided as roundbiconvex enteric-coated tablets matching tablets of HBS-301. The tablets are blue-violet. he tablets are also debossed on 1 side with “”."biconvex enteric-coated tablets matching of HBS-301. The tablets are beige to light brown. The tablets are also debossed on 1 side with “”."biconvex enteric-coated tablets matching tablets of HBS-301. The tablets are blue-green. he tablets are also debossed on 1 side with “”."

Every trial of Pitolisant across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Change in severity of EDS as measured by the ESS from Baseline to the end of the Double-blind Treatment Period

Endpoint detail

1. Change in severity of IH symptoms as measured by the IHSS from Baseline to the end of the Double-blind Treatment Period, 2. Change in sleep inertia as measured by the SIQ from Baseline to the end of the Double-blind Treatment Period, 3. Change in fatigue as measured by the from Baseline to the end of the Double-blind Treatment Period, 4. Change in severity of EDS as measured by the ESS from Baseline through Week 2 of the Titration Period, 5. Change in severity of EDS as measured by the ESS from Baseline through Week 1 of the Titration Period, 6. Change in severity of IH symptoms as measured by the IHSS from Baseline through Week 2 of the Titration Period, 7. Change in severity of IH symptoms as measured by the IHSS from Baseline through Week 1 of the Titration Period

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523822-42-00 on CTIS ↗ ← All trials in the EU