Trial Profile

A Phase 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Determine the Safety and Efficacy of Oral SDX in Patients With Idiopathic Hypersomnia (IH)

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 25 Apr 2025

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At a glance

21 Apr 2025 According to a Zevra Therapeutics Media release, the company completed the end-of-Phase 2 meeting at Q3 2024 with FDA, and reached an alignment that a single pivotal Phase 3 trial design with appropriate confirmatory evidence would be enough to submit the NDA.
24 Sep 2024 According to a Zevra Therapeutics Media release, topline data form this trial will be presented at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS) being held in Seville, Spain, September 24-27, 2024.
30 Jul 2024 Status changed from active, no longer recruiting to completed.

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