A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome (NCT07503444)
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
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to investigate the efficacy of fenfluramine hydrochloride (HCl) versus placebo in study participants with Rett syndrome (RTT).
Who can join: Review the eligibility criteria below.
Location: Ep0247 21010 — Little Rock, Arkansas
Age range: 5 Years to 35 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- Ep0247 21010 — Little Rock, Arkansas
- Ep0247 21011 — Orlando, Florida
- Ep0247 21007 — Atlanta, Georgia
- Ep0247 21005 — Houston, Texas
- Ep0247 21013 — Irving, Texas
- Ep0247 11001 — Brussels,
- Ep0247 12005 — Brest,
- Ep0247 15001 — Budapest,
- Ep0247 15002 — Debrecen,
- Ep0247 17006 — Troina,
- Ep0247 43004 — Kodaira,
- Ep0247 43006 — Musashimurayama-shi,
- Ep0247 43002 — Osaka,
- Ep0247 43003 — Setagaya-ku,
- Ep0247 19002 — Krakow,
- Ep0247 11105 — Madrid,
- Ep0247 11103 — Málaga,
- Ep0247 11102 — Seville,
📞 Contact the Study Coordinator
Phone: (844) 599-2273
Email: ucbcares@ucb.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rett Syndrome
- Safety and Efficacy of TSHA-102 in Pediatric Females With Rett Syndrome (REVEAL Pediatric Study) — Chicago, Illinois
- Safety and Preliminary Efficacy of TSHA-102 Gene Therapy in Pediatric Females Aged >2 to <4 Years With Rett Syndrome — Birmingham, Alabama
- Technology-supported Motor Rehabilitation for People With Rett Syndrome — Bethesda, Maryland
- A Phase 1/2/3 Study of TSHA-102 Gene Therapy in Females With Rett Syndrome (REVEAL Pivotal Study) — Duarte, California
- A Novel, Regulated Gene Therapy (NGN-401) Study for Females With Rett Syndrome — Birmingham, Alabama
- A Pilot Study of an Antioxidant Cocktail vs. Placebo in the Treatment of Children and Adolescents With Rett Syndrome — Toronto, Ontario
Explore by condition: All Rett Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.