Fenfluramine for Dravet and Lennox-Gastaut Syndromes
What You Need to Know Before You Apply
What is the purpose of this trial?
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
Who Is on the Research Team?
UCB Cares
Principal Investigator
001 844 599 2273
Are You a Good Fit for This Trial?
This trial is for children and adults with rare seizure disorders like Dravet syndrome or Lennox-Gastaut syndrome, who have completed a prior Zogenix study. Participants must not be pregnant, breastfeeding, have serious liver issues, heart valve problems or pulmonary hypertension, nor take certain medications affecting serotonin within 14 days of the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ZX008 (Fenfluramine Hydrochloride) oral solution as an adjunctive therapy for seizures
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive ZX008 for an extended period to assess long-term safety
What Are the Treatments Tested in This Trial?
Interventions
- ZX008 (Fenfluramine Hydrochloride)
ZX008 (Fenfluramine Hydrochloride) is already approved in European Union, United States, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zogenix, Inc.
Lead Sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Industry Sponsor