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

Condition studied

narcolepsy

Investigational medicinal product(s)

Every trial of Pitolisant across our registers →

Eligibility

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. WRC at the end of the Double-blind Treatment Period in participants with an CCI weeks during Screening, 2. Change in sleepiness/wakefulness as measured by the MWT from Baseline to the end of the Double-blind Treatment Period, 3. Zmiana w CCI mierzona za pomocą CCI od wizyty wyjściowej do zakończenia okresu leczenia prowadzonego metodą podw. ślepej próby, 4. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 5. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 6. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening, 7. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening