RECRUITING: Phase 3 fenfluramine trial – Europe, Japan and USA

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Status: RecruitingStudy: Phase 3 study of fenfluramine hydrochloride in Rett syndrome
Registry number: NCT07503444
Countries: Belgium, France, Hungary, Italy, Japan, Poland, Spain and the United States
Age range: 5–35 years; male and female participants

What is being studied?
This Phase 3 study compares fenfluramine hydrochloride with placebo in people with typical/classic Rett syndrome and a documented disease-causing MECP2 variant. Researchers are assessing whether treatment improves Rett symptoms and monitoring safety.

Recruiting locations currently include Madrid, Málaga and Seville in Spain; sites in Belgium, France, Hungary, Italy, Japan and Poland; and several US sites.

Contact: UCB Cares — +1 844 599 2273 — ucbcares@ucb.com
Official study record: https://clinicaltrials.gov/study/NCT07503444

Information checked 3 September 2026. Recruitment status and eligibility can change. Contact the study team and discuss participation with the person’s Rett specialist; this post is for information, not medical advice.