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

Open-Label, Single-Arm, Phase 3 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 1 Year – 23 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
DRUG	fenfluramine	The study drug, fenfluramine HCl, is an oral solution to be administered in equal doses twice daily (BID). It will be based on the current dose and participant's weight (kg).

Timeline

• Start date: 2024-05-21
• Primary completion: 2026-09-03
• Completion: 2026-12-16
• First posted: 2023-11-07
• Last updated: 2026-04-03

Locations

12 sites across 5 countries: United States, Belgium, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated drug study