clinical trial · NCT02823145
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.·phase3·completed·n = 375
Dravet SyndromeZX008 (Fenfluramine Hydrochloride)
brief summary
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
started
Jun 8, 2016
primary completion
Jan 27, 2023
completion
Jan 27, 2023
last updated
Jul 14, 2025
detailed description
This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who participated in one of the core studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an extended period of time. This trial will consist of a 36-month Open-Label Extension (OLE) Treatment Period and a 2-week Post-Dosing Period.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol