At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 375 enrolled
Drug / intervention
ZX008 (Fenfluramine Hydrochloride)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.·interventional·Posted Jul 6, 2016·Updated Jul 14, 2025
In Brief
A Phase 3 clinical trial evaluating ZX008 (Fenfluramine Hydrochloride) for Dravet Syndrome. Completed, enrolled 375 participants across 67 sites in 12 countries.
Detailed Summary
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDravet Syndrome
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJun 2016
First PostedJul 2016
Primary CompletionJan 2023
TodayJul 2026
First PostedJul 6, 2016
Enrollment StartJun 8, 2016
Primary CompletionJan 27, 2023
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 10.0 years ago
Interventions
ZX008 (Fenfluramine Hydrochloride)drug