drugset / Trial / NCT05064878
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 3 Study to examine the efficacy and safety of ZX008 in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).
Timeline
- Start
- 2022-03-08
- Primary completion
- 2027-11-08
- Completion
- 2027-11-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenfluramine | Small molecule | 0.5 mg/kg | Oral |
| Subject | Fenfluramine | Small molecule | 0.8 mg/kg | Oral |