Fenfluramine for Rett Syndrome

A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome

Recruiting Phase 3 Interventional Study
Rett Syndrome
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
5 – 35
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
UCB BIOSCIENCES, Inc. · Industry
Who this trial is looking for

This trial is looking for people with Rett syndrome to see if fenfluramine can help. Participants will be monitored and complete caregiver assessments during the study.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with typical Rett Syndrome.
  • I have a mutation in the MECP2 gene.
  • I haven't lost any skills in walking, hand function, or communication for at least 6 months.
  • I have a Rett Syndrome Clinical Severity Scale rating between 10 and 36.
  • I have a Clinical Global Impression-Severity score of 4 or higher.
  • I am between 5 and 35 years old.
  • I have a caregiver who can help me during the study.

You may not be able to join if

  • I have had any type of cancer in the last 5 years, except some skin cancers.
  • I have major issues with my vital signs.
  • I have significant heart problems that don't allow me to join the study.
  • I have a serious medical condition like chronic lung disease.
  • I need more than 4 ant seizure medications.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participant has typical or classic Rett Syndrome (RTT) according to the RettSearch Consortium 2010 revised criteria * Participant has a documented disease-causing mutation or deletion in the methyl-CpG-binding protein 2 (MECP2) gene * Participant meets criteria for postregress…
Contacts

UCB Cares

+18445992273

ucbcares@ucb.com

CONTACT

UCB Cares

0018445992273

UCBCares@ucb.com

CONTACT