A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
Phase of Trial: Phase III
Latest Information Update: 11 Aug 2017
At a glance
- Drugs Fenfluramine (Primary)
- Indications Dravet syndrome
- Focus Registrational; Therapeutic Use
- Sponsors Zogenix
- 09 Mar 2027 Study 1 is a merged study analysis whereby top-line results from the first half of the combined patient population of studies 1501 and 1502 would be reported as Study 1 which will include the first 120 patients, and potentially Study 2 for the remaining patients. ( Reference: https://baystreet.ca/articles/research_reports/lifesci/Zogenix021517.pdf and http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-SECText&TEXT)
- 03 Jul 2017 Planned End Date changed from 1 Jul 2017 to 1 Dec 2018.
- 03 Jul 2017 Planned primary completion date changed from 1 Jun 2017 to 1 Dec 2018.