A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

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. Key secondary objectives of this study are to assess the impact of pitolisant on: * Overall symptoms of IH * Patient impression of overall change in their symptoms of IH * Investigator assessment of overall disease severity of IH Other secondary objectives of this study are to assess the impact of pitolisant in patients with IH on: * Patient impression of overall severity of their EDS * Functional status and activities of daily living * Sleep-related impairment * Sleep inertia * Cognitive function

Timeline

Start

2022-05-25

Primary completion

2023-09-08

Completion

2023-09-08

Drugs

Indications