CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 412 enrolled
Drug / intervention
ZX008 (Fenfluramine Hydrochloride)drug
Likely dose
ZX008 (Fenfluramine Hydrochloride) 2.5 mgfrom 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.

Search/NCT03936777
NCT03936777Phase 3Completed
CompareCT.gov

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

Zogenix, Inc.·interventional·Posted May 3, 2019·Updated Nov 17, 2025

In Brief

A Phase 3 clinical trial evaluating ZX008 (Fenfluramine Hydrochloride) for Dravet Syndrome and 2 related conditions. Completed, enrolled 412 participants across 71 sites in 14 countries.

Detailed Summary

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDravet Syndrome, Lennox Gastaut Syndrome, Epileptic Encephalopathy
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Italy, Mexico, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
CollaboratorsZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 3, 2019
Enrollment StartApr 22, 2019
Primary CompletionMay 8, 2025
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 7.2 years ago

Interventions

ZX008 (Fenfluramine Hydrochloride)drug

Fenfluramine hydrochloride provided in a concentration of 2.5 mg/mL.