ZX008 Adjunctive Therapy in Children with Dravet Syndrome

• Research type

  Research Study

• Full title

  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

• IRAS ID

  191351

• Contact name

  J Helen Cross

• Sponsor organisation

  Brabant Pharma Ltd

• Eudract number

  2015-004167-37

• Clinicaltrials.gov Identifier

  NCT02682927

• Duration of Study in the UK

  2 years, 0 months, 16 days

• Research summary

  The primary objective of the study is to demonstrate that the study drug (ZX008) is superior to a placebo as adjunctive therapy (given in addition to the primary, main, or initial therapy) in the treatment of Dravet syndrome (a rare and catastrophic form of intractable epilepsy that begins in infancy) in children and young adults in the frequency of convulsive seizures.

  The safety objective of the study is to compare the safety and tolerability of ZX008 with regard to adverse events (AEs), laboratory parameters, physical examination, neurological examination, vital signs (blood pressure, heart rate, temperature, and respiratory rate), electrocardiograms (ECG), echocardiograms (ECHO), and body weight. Cognitive Function will be assessed using ageappropriate versions of the BRIEF

• REC name

  London - Central Research Ethics Committee

• REC reference

  16/LO/0537

• Date of REC Opinion

  17 May 2016

• REC opinion

  Further Information Favourable Opinion