Trial Profile

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 17 Mar 2025

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At a glance

Drugs Fenfluramine (Primary)
Indications Dravet syndrome
Focus Adverse reactions; Registrational
Sponsors Zogenix

Most Recent Events

12 Mar 2025 According to UCB media release, the final analysis of the long-term open-label extension (OLE) study evaluating the safety and effectiveness of FINTEPLA(fenfluramine) in patients with Dravet syndrome
12 Mar 2025 Results published in the UCB Media Release
22 Sep 2023 primary endpoints has been amended

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