Overview

A Two-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥2 Years Old and Young Adults With Dravet Sy

Status:
Completed

Trial end date:
2019-01-08

Target enrollment:

Participant gender:

Summary

The primary purpose of this study is to evaluate the safety, tolerability and efficacy of a single dose of ZX008 (Fenfluramine Hydrochloride) when added to standard of care and when added to Adjunctive Antiepleptic therapy to Stiripentol treatment in children and young adults with Dravet Syndrome

Phase:

Phase 3

Details

Lead Sponsor:

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

Treatments:

Fenfluramine
Pharmaceutical Solutions