OLE Long-Term Safety of ZX008 for Patients with Rare Seizure Disorders

• 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 for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

• IRAS ID

  270577

• Contact name

  Rebecca Hefford

• Contact email

  rebecca.hefford@parexel.com

• Sponsor organisation

  Zogenix International Limited

• Eudract number

  2019-001331-31

• Clinicaltrials.gov Identifier

  NCT03936777

• Clinicaltrials.gov Identifier

  125797, IND Number

• Duration of Study in the UK

  5 years, 0 months, 18 days

• Research summary

  The rationale for conducting this open label extension study is primarily to evaluate the long-term safety and tolerability of ZX008 in patients with rare seizure disorders such as Dravet Syndrome and Lennox-Gastaut Syndrome. This protocol also provides an opportunity for continued treatment with ZX008 for subjects already enrolled in the parent study ZX008-1503. Participation for subjects will be up to 36 months or until ZX008 is approved in the subject's country of residence and listed on a patient's health plan formulary, whichever occurs first.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  19/LO/1612

• Date of REC Opinion

  7 Nov 2019

• REC opinion

  Further Information Favourable Opinion