FX-LEARN – Clinical Trial for Language Learning of AFQ056 in Children

The purpose of this NeuroNEXT (Network for Excellence in Neuroscience Clinical Trials) study is to find out if the drug AFQ056, made by the pharmaceutical company Novartis, is safe and has beneficial effects on language learning in children who have Fragile X syndrome (FXS). The study also aims to find out if a structured language intervention can help children with Fragile X syndrome communicate better.

The phase II study is coordinated by NeuroNEXT, with support and funding from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH). Dr. Elizabeth Berry-Kravis at Rush University is the Protocol Principal Investigator and is leading this national Fragile X clinical trial.

Children with a diagnosis of Fragile X syndrome between the ages of 32 months and 6 years who can swallow a liquid medication may be eligible. This is a national Fragile X clinical trial being conducted at the following centers:

  • Boston Children’s Hospital – Boston, MA
  • Children’s Health – Children’s Medical Center (UTSW) – Dallas, TX
  • Children’s Hospital of Colorado – Denver, CO
  • Children’s Hospital of Pittsburgh – Pittsburgh, PA
  • Children’s National Medical Center – Washington D.C.
  • Cincinnati Children’s Hospital Medical Center – Cincinnati, OH*
  • Columbia University – New York Presbyterian – New York, NY*
  • Emory University – Atlanta, GA
  • Nationwide Children’s Hospital – Columbus, OH
  • Rush University Medical Center – Chicago, IL*
  • Louis Children’s Hospital – St. Louis, MO
  • University of California – Davis, CA*
  • University of Kansas Medical Center – Kansas City, KS
  • Vanderbilt University Medical Center – Nashville, TN*

*Actively recruiting as of mid-January 2018

Additional Details

National Study Coordinator

Katherine J Friedmann, RN
(312) 942-9841