This study is accepting new patients by invitation only

A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

a study on Dravet Syndrome Lennox-Gastaut Syndrome Epileptic Encephalopathy

Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
estimated completion

Description

Summary

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

Official 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

Details

This is an international, multicenter, open-label, long-term safety study of ZX008 in patients with epileptic encephalopathy, including Dravet syndrome or Lennox-Gastaut syndrome. Subjects eligible for participation are those with Dravet syndrome who are currently enrolled in Study ZX008-1503, or those with Lennox-Gastaut syndrome who have successfully completed Study ZX008-1601-Part 2, and are candidates for continued treatment with ZX008 for an extended period of time, or those with Dravet syndrome, Lennox-Gastaut syndrome, or another epileptic encephalopathy who have completed participation in another Zogenix-sponsored study and have been invited to participate in this study.

Keywords

Dravet Syndrome Lennox Gastaut Syndrome Epileptic Encephalopathy Brain Diseases Epilepsy Epilepsies, Myoclonic Syndrome Fenfluramine ZX008 (Fenfluramine Hydrochloride)

Eligibility

You can join if…

Open to people ages 2 years and up

  • Male or nonpregnant, nonlactating female
  • Satisfactory completion of a core study
  • Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with ZX008
  • Subject's caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability

You CAN'T join if...

  • Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
  • Moderate or severe hepatic impairment
  • Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • University of California San Francisco
    San Francisco California 94158 United States
  • Rady's Childrens Hospital
    San Diego California 92123 United States
  • Children's Hospital of Orange County
    Orange California 92868 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Zogenix, Inc.
ID
NCT03936777
Phase
Phase 3
Study Type
Interventional
Last Updated