An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008

• Research type

  Research Study

• Full title

  An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome

• IRAS ID

  213198

• Contact name

  Helen Cross

• Contact email

  helen.cross@gosh.nhs.uk

• Sponsor organisation

  Zogenix International Limited

• Eudract number

  2016-002804-14

• Clinicaltrials.gov Identifier

  NCT02823145

• Duration of Study in the UK

  years, months, days

• Research summary

  The rationale for conducting this open-label extension study is primarily to evaluate the long-term safety of ZX008 in Dravet Syndrome. This protocol also provides the opportunity for continued treatment for subjects responding to treatment from the core study, and an opportunity for initial treatment with ZX008 for subjects randomized to placebo in the core study

  Research summary:
  This Plain Language Summary of Study Results will be disclosed on https://www.ucb.com/clinical-studies/Clinical-studies-index/Plain-language-Summaries once the clinical results are made available on https://www.clinicaltrials.gov/ and other registries.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  16/LO/1624

• Date of REC Opinion

  8 Nov 2016

• REC opinion

  Further Information Favourable Opinion