Study: FX-LEARN – Language Learning in Children with FXS

AFQ056 for Language Learning in Children with Fragile X Syndrome (NN107)

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- to 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).

To learn more information, please visit http://www.neuronext.org or https://clinicaltrials.gov/show/NCT02920892.

National Study Coordinator

Katie Friedmann RN
312-942-9841
Katherine_j_friedmann@rush.edu

 

Locations

Rush University Medical Center – Recruiting
Contact: Anna Desonia :  (312) 942-7250 or Katie Friedmann 312-942-9841
Chicago, Illinois, 60612
Principal Investigator: Elizabeth Berry-Kravis MD PhD

 

Boston Children’s Hospital- Recruiting
Boston, Massachusetts, 02115
Contact: Sofia Georghiou – 617-919-3554
Principal Investigator: Lisa Prock, MD MPH

 

Children’s Health- Children’s Medical Center (UTSW) – Not yet recruiting
Dallas, Texas, 75390-8855
Contact: Deanna Myer 214-648-2926
Principal Investigator: Sailaja Golla, MBBS

 

Children’s Hospital of Colorado – Recruiting
Denver, Colorado, 80045-7106
Contact: Nanastasia Welnick – 720-777-8606
Gina VanderVeen – 720-777-5514
Principal investigator: Nicole Tartaglia, MD

 

Children’s Hospital of Pittsburgh – Recruiting
Pittsburgh, Philadelphia, 15213
Contact: Christine Amity – 412-383-7549
Principal Investigator: Robyn Filipink, MD

 

Children’s National Medical Center- Recruiting
Washington D.C., 20010
Contact: Tracy Bui – 202-476-6551
Principal Investigator: Andrea Gropman, MD

 

Cincinnati Children’s Hospital Medical Center- Recruiting
Cincinnati, Ohio, 45229
Contact: Nicole McCoy – 513-636-0526
Hilary Rosselot- 513-636-4134
Principal Investigator: Craig Erickson, MD

 

Columbia University- New York Presbyterian – Recruiting
White Plains, New York, 10605
Contact: Joyce Ann Moran – 212-305-8367
Elizabeth Aaron-  914-997-5242
Principal Investigator: Jeremy Veenstra-VanderWeele, MD

 

Emory University – Not yet recruiting
Atlanta, Georgia, 30033
Contact: Jean Luan McColl – 404-778-8619
Principal Investigator: Amy Talboy, MD, FAAP

 

Nationwide Children’s Hospital- Recruiting
Columbus, Ohio, 43205
Contact: Rachel Heffern- 614-722-4684
Principal Investigator: Lenora Lehwald, MD

 

St. Louis Children’s Hospital (Washington University School of Medicine)- Recruiting
St. Louis, Missouri, 63110
Contact: Kathleen Black- 314-362-7166
Mengesha Teshome- 314-747-8420
Principal Investigator: Bryan McGill, MD, PhD

 

UC Davis – Recruiting
Davis, California, 95817
Contact: Erika Bickel – 916-703-0281
Principal Investigator: Randi Hagerman, MD

 

Vanderbilt University Medical Center- Recruiting
Nashville, Tennessee, 37232
Contact: Rebecca Kaiser- 615-343-4590
Principal Investigator: Angela Maxwell-Horn, MD