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

Inclusion criteria

• ✓. Is able to provide voluntary, written informed consent.
• ✓. Has a current diagnosis of IH per International Classification of Sleep Disorders Third Edition (ICSD 3) criteria.
• ✓. Male or female patient age ≥18 years at the time of Screening.
• ✓. Has an ESS score of ≥12 at Screening and at Baseline (Visit 2).
• ✓. Has a PGI-S score of moderate, severe, or very severe at Screening and at Baseline (Visit 2).
• ✓. For patients being treated for OSA or other hypoventilatory conditions, patients must be compliant as demonstrated by BiPAP/CPAP therapy with 30 days of data showing ≥4 hours of BiPAP/CPAP therapy per night for ≥70% of nights. If not on BiPAP/CPAP therapy, patients being treated for OSA must be compliant as determined by the Investigator with their medical device or oral appliance. Data must be from within 90 days prior to the Screening visit. Patients must agree to maintain compliance with their treatment for OSA throughout the duration of the study.
• ✓. If on a treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil):
• ✓. Must be on a stable dose for at least 2 months prior to Screening and agree to continue the stable dose for the duration of the study.