An Open Label Expanded Access Program Intended to Provide Treatment with HBS-101 (Pitolisant) to Adult Patients in the U.S. with Excessive Daytime Sleepiness Associated with Narcolepsy with or without Cataplexy

Brief description of study

This is an expanded access program for the investigational medication pitolisant. Pitolisant is a medicine used to treat adult patients with excessive daytime sleepiness associated with narcolepsy as well as those who have cataplexy associated with narcolepsy. Approximately, 400 patients will enroll at approximately 40 locations throughout the U.S. The purpose of the study is to provide access to treatment with pitolisant, while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval, to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. In addition, the study will examine the safety and tolerability profile of pitolisant in adult patients with EDS associated with narcolepsy with or without cataplexy.

Clinical Study Identifier: s19-00473 Identifier: NCTs19-00473