A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)
Phase of Trial: Phase III
Latest Information Update: 15 Sep 2017
At a glance
- Drugs Fenfluramine (Primary)
- Indications Dravet syndrome
- Focus Registrational; Therapeutic Use
- Sponsors Zogenix
- 09 Sep 2017 Planned End Date changed from 1 Aug 2017 to 1 Jun 2018.
- 09 Sep 2017 Planned primary completion date changed from 1 Aug 2017 to 1 Jun 2018.
- 08 Aug 2017 According to a Zogenix media release, the company has enrolled approximately two-thirds of the targeted number of subjects. Enrollment is expected to complete by the end of the current quarter.