Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 11 Oct 2023

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At a glance

05 Oct 2023 According to a Harmony Biosciences media release, data from this study were presented at the 2023 Foundation for Prader-Willi Research (FPWR) Symposium and Family Conference.
05 Oct 2023 Results presented in a Harmony Biosciences Media Release.
20 Jul 2023 According to a Harmony Biosciences media release, the company has successfully completed an End-of-Phase 2 meeting with FDA regarding plan evaluating pitolisant as a potential treatment for excessive daytime sleepiness (EDS) in patients ages six and older with Prader-Willi syndrome (PWS).

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