NCT02823145

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (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 an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

Detailed description

This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who participated in one of the core studies (ZX008-1501 and ZX008-1502) and are candidates for continuous treatment for an extended period of time. This trial will consist of a 36-month Open-Label Extension (OLE) Treatment Period and a 2-week Post-Dosing Period.

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
DRUG	ZX008 (Fenfluramine Hydrochloride)

Timeline

• Start date: 2016-06-08
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2016-07-06
• Last updated: 2025-07-14
• Results posted: 2023-09-25

Locations

67 sites across 12 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study