NCT06118255View on ClinicalTrials.gov

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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 21, 2024

Primary Completion Date

September 3, 2026

Study Completion Date

November 20, 2026

Conditions
Dravet Syndrome
Interventions
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).

Trial Locations (15)

75207

Ep0213 107, Dallas

98105

Ep0213 103, Seattle

38103-2800

Ep0213 105, Memphis

Unknown

Ep0213 502, Brussels

Ep0213 501, Edegem

Ep0213 303, Bielefeld

Ep0213 202, Florence

Ep0213 203, Genova

Ep0213 201, Roma

Ep0213 204, Roma

Ep0213 603, Madrid

Ep0213 604, Madrid

Ep0213 602, Pamplona

Ep0213 403, Glasgow

Ep0213 401, London

All Listed Sponsors
lead

UCB BIOSCIENCES, Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter