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

• Status: Enrolling by invitation
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zogenix, Inc.
• Collaborator: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
• Treatments: Fenfluramine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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