A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Multicenter, Randomized, Double-blind, Parallel Group, 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 Trial to Assess Long-Term Safety of ZX008 in Children and Adults With LGS
Phase of Trial: Phase III
Latest Information Update: 21 Mar 2018
At a glance
- Drugs Fenfluramine (Primary)
- Indications Lennox-Gastaut syndrome
- Focus Therapeutic Use
- Sponsors Zogenix
- 06 Mar 2018 According to a Zogenix Provides media release, data for this study will be used by the company for the regulatory approvals in the USA and Europe of ZX008 in patients with Lennon-Gastaut syndrome (LGS).
- 29 Nov 2017 Status changed from not yet recruiting to recruiting, according to a Zogenix media release.
- 29 Nov 2017 According to a Zogenix media release, Kelly Knupp from Childrens Hospital Colorado is the Principal Investigator of the U.S. arm of the trial.