drugset / Trial / NCT06118255
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome
NaSingle-groupOpen-labelTreatment
Summary
The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.
Timeline
- Start
- 2024-05-21
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fenfluramine | Small molecule | 0.2 mg/kg | Oral |
| Subject | Fenfluramine | Small molecule | 0.8 mg/kg | Oral |