CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 296 enrolled
Drug / intervention
ZX008 0.2 or 0.8 mg/kg/day +1 moredrug
Likely dose
ZX008 0.2 or 0.8 mg/kg/dayfrom 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/NCT03355209
NCT03355209Phase 3Completed
CompareCT.gov

A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.·interventional·Posted Nov 28, 2017·Updated Jul 3, 2025

In Brief

A Phase 3 clinical trial evaluating ZX008 0.2 or 0.8 mg/kg/day and Matching Placebo for Lennox Gastaut Syndrome. Completed, enrolled 296 participants across 72 sites in 14 countries.

Detailed Summary

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLennox Gastaut Syndrome
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 28, 2017
Enrollment StartNov 27, 2017
Primary CompletionMay 23, 2024
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 8.6 years ago

Interventions

ZX008 0.2 or 0.8 mg/kg/daydrug

ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.

Matching Placebodrug

Placebo will be administered twice a day (BID) in equally divided doses.