RecruitingPhase 3NCT07503444

A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome

A Phase 3 Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study With Open-Label Extension to Evaluate the Efficacy And Safety of Fenfluramine Hydrochloride in Study Participants With Rett Syndrome

Sponsor

UCB BIOSCIENCES, Inc.

Enrollment

200 participants

Start Date

Jul 14, 2026

Study Type

INTERVENTIONAL

Conditions

Rett Syndrome

Summary

The purpose of this study is to investigate the efficacy of fenfluramine hydrochloride (HCl) versus placebo in study participants with Rett syndrome (RTT).

Eligibility

Min Age: 5 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a drug called fenfluramine hydrochloride for people with rett syndrome. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 5 Years to 35 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGfenfluramine hydrochloride

Oral solution

OTHERPlacebo

Oral solution

Locations(23)

Ep0247 21010

Little Rock, Arkansas, United States

Ep0247 21009

Miami, Florida, United States

Ep0247 21011

Orlando, Florida, United States

Ep0247 21007

Atlanta, Georgia, United States

Ep0247 21005

Houston, Texas, United States

Ep0247 21013

Irving, Texas, United States

Ep0247 11001

Brussels, Belgium

Ep0247 12005

Brest, France

Ep0247 12006

Paris, France

Ep0247 15001

Budapest, Hungary

Ep0247 15002

Debrecen, Hungary

Ep0247 17008

Naples, Italy

Ep0247 17002

Pisa, Italy

Ep0247 17006

Troina, Italy

Ep0247 43004

Kodaira, Japan

Ep0247 43001

Kurume, Japan

Ep0247 43006

Musashimurayama-shi, Japan

Ep0247 43002

Osaka, Japan

Ep0247 43003

Setagaya-ku, Japan

Ep0247 19002

Krakow, Poland

Ep0247 11105

Madrid, Spain

Ep0247 11103

Málaga, Spain

Ep0247 11102

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT07503444

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