NCT03355209

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. · Industry
• Sex: All
• Age: 2 Years – 35 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-11-27
• Primary completion: 2024-05-23
• Completion: 2024-05-23
• First posted: 2017-11-28
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

72 sites across 14 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study