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 Prader Willi syndrome (PWS) ages 6 to 65 years.
Phase 2 trials begin testing efficacy in a larger patient group (100–300). This is often where biotech binary events occur — positive Phase 2 data can significantly advance a company's pipeline narrative, while failures can be terminal for a program.
This trial has completed. Results may be available via ClinicalTrials.gov or peer-reviewed publications.
Harmony Biosciences (HRMY) is the sponsoring company for this trial. BiotechSign currently grades this company D (46/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.