Clinical Trial

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

Study acronym: ORCHID
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
minor Completion moved earlier: 2026-12-16 -> 2026-09-01 2026-06-16
Trial Details
NCT Number NCT06118255
Lead Sponsor UCB BIOSCIENCES, Inc.
Conditions Dravet Syndrome
Enrollment 25 participants
Start Date 2024-05-21
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07