Loading clinical trials...
Loading clinical trials...
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
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
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.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
Ep0215 107
Tucson, Arizona, United States
Ep0215 144
Los Angeles, California, United States
Ep0215 108
San Diego, California, United States
Ep0215 101
San Francisco, California, United States
Ep0215 103
Aurora, Colorado, United States
Ep0215 115
Gulf Breeze, Florida, United States
Ep0215 104
Miami, Florida, United States
Ep0215 141
Orlando, Florida, United States
Ep0215 121
Winter Park, Florida, United States
Ep0215 117
Atlanta, Georgia, United States
Start Date
April 22, 2019
Primary Completion Date
May 8, 2025
Completion Date
May 8, 2025
Last Updated
November 17, 2025
412
ACTUAL participants
ZX008 (Fenfluramine Hydrochloride)
DRUG
Lead Sponsor
Zogenix, Inc.
Collaborators
NCT05419492
NCT05066217
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04462770