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A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

NCT03355209 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2025-07-03

Study results available
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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).

Conditions

  • Lennox Gastaut Syndrome

Interventions

DRUG

ZX008 0.2 or 0.8 mg/kg/day

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.

DRUG

Matching Placebo

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

Sponsors & Collaborators

  • Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2024-05-23
Completion
2024-05-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355209 on ClinicalTrials.gov