AFQ056 for Language Learning in Children With FXS

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

August 17, 2017

Primary Completion Date

May 17, 2022

Study Completion Date

May 17, 2022

Conditions
Fragile X Syndrome
Interventions
DRUG

AFQ056

12.5 mg - 100 mg oral suspension (liquid)

DRUG

Placebo

Placebo oral suspension (liquid)

OTHER

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."

Trial Locations (14)

10605

Columbia University - New York Presbyterian, New York

15213

Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

30033

Emory University, Atlanta

37232

Vanderbilt University Medical Center, Nashville

43205

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60612

Rush University Medical Center, Chicago

63110

St Louis Children's Hospital (Washington University School of Medicine), St Louis

80045

Children's Hospital of Colorado, Denver

95817

Univeristy of California - Davis, Davis

06520

Yale University, New Haven

02115

Boston Children's Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Elizabeth Berry-Kravis

OTHER