drugset / Trial / NCT03936777
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
Phase 3
Completed
412 enrolled
Zogenix, Inc.
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. · collab
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2019-04-22
- Primary completion
- 2025-05-08
- Completion
- 2025-05-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenfluramine | Small molecule | 0.5 mg/kg | Oral |
| Subject | Fenfluramine | Small molecule | 0.8 mg/kg | Oral |
| Subject | Fenfluramine | Small molecule | 20 mg | Oral |
| Subject | Fenfluramine | Small molecule | 30 mg | Oral |