110
Participants
Start Date
August 17, 2017
Primary Completion Date
May 17, 2022
Study Completion Date
May 17, 2022
AFQ056
12.5 mg - 100 mg oral suspension (liquid)
Placebo
Placebo oral suspension (liquid)
Language Intervention
"All subjects will begin an intensive language intervention 2 months after starting treatment with AFQ056 or placebo and will continue the intervention through the end of the study.~The language intervention will be administered by a trained language specialist through a combination of in clinic visits and at home synchronous video conferencing sessions. The intervention will subsequently be delivered to the parent by a speech-language clinician through weekly clinician coaching, homework, and feedback sessions.~The language intervention is designed to help parents learn and use verbally responsive interactional strategies more frequently and effectively throughout the course of their daily interactions with their children."
Columbia University - New York Presbyterian, New York
Children's Hospital of Pittsburgh, Pittsburgh
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
Emory University, Atlanta
Vanderbilt University Medical Center, Nashville
Nationwide Children's Hospital, Columbus
Cincinnati Children's Hospital Medical Center, Cincinnati
Rush University Medical Center, Chicago
St Louis Children's Hospital (Washington University School of Medicine), St Louis
Children's Hospital of Colorado, Denver
Univeristy of California - Davis, Davis
Yale University, New Haven
Boston Children's Hospital, Boston
Collaborators (1)
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Novartis Pharmaceuticals
INDUSTRY
Elizabeth Berry-Kravis
OTHER