Overview

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with idiopathic hypersomnia (IH) age ≥18 years. The secondary objectives of this study are to assess the impact of pitolisant on: - Patient impression of the overall change in their IH - Evaluation of overall symptoms of IH - Investigator assessment of overall disease severity of IH - Functional status and activities of daily living in patients with IH - Sleep-related impairment in patients with IH - Sleep inertia in patients with IH - Cognitive function in patients with IH
Phase:
Phase 3
Details
Lead Sponsor:
Harmony Biosciences, LLC