CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
AFQ056 +2 moredrug
Likely dose
AFQ056 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02920892
NCT02920892Phase 2Completed
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Effects of AFQ056 on Language Learning in Young Children With Fragile X Syndrome (FXS)

Elizabeth Berry-Kravis·interventional·Posted Sep 30, 2016·Updated Oct 10, 2023

In Brief

A Phase 2 clinical trial evaluating AFQ056, Placebo, and 1 other intervention for Fragile X Syndrome. Completed, enrolled 110 participants across 14 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Syndrome
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), Novartis Pharmaceuticals

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 30, 2016
Enrollment StartAug 17, 2017
Primary CompletionMay 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.8 years ago

Interventions

AFQ056drug

12.5 mg - 100 mg oral suspension (liquid)

Placebodrug

Placebo oral suspension (liquid)

Language Interventionother

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.