NN107 FX-LEARN is currently looking to enroll children with Fragile X Syndrome (FXS) for a research study conducted by the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). Dr. Elizabeth Berry-Kravis at Rush University is the Protocol Principal Investigator and is leading this national study. The National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), is supporting this trial.
There are two purposes of this study. First, to find out if the drug AFQ056, made by the pharmaceutical company Novartis, is safe and has beneficial effects on learning in children who have fragile X syndrome (FXS). Second, to find out if a structured language intervention can help children with fragile X syndrome communicate better.
The trial will be a multi-center, phase II randomized, double blind placebo-controlled parallel-group flexible-dose forced-titration study that will use a novel design to address the impact of AFQ056 on language learning in 3-6 year old children with FXS. Subjects will be in the study a total of 21 months (Screening and 12 months placebo-controlled treatment, 8 months open-label extension, 1 month follow up after final assessment visit).
National Coordinator Study
Katherine J Friedmann, RN
Elizabeth Berry-Kravis, MD, PhD
Rush University Medical Center