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AFQ056 for Language Learning in Children With FXS

NCT02920892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-10-10

Study results available
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Summary

The purpose of this clinical trial is to investigate the impact of AFQ056 on language learning in 3-6 year old children with Fragile X Syndrome (FXS).

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Elizabeth Berry-Kravis

    lead OTHER

Principal Investigators

  • Elizabeth Berry-Kravis, MD, PhD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
32 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-17
Primary Completion
2022-05-17
Completion
2022-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02920892 on ClinicalTrials.gov