# Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

> **NCT01433354** · PHASE2,PHASE3 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 119 (actual)

## Conditions studied

- Fragile X Syndrome

## Interventions

- **DRUG:** AFQ056

## Key facts

- **NCT ID:** NCT01433354
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2011-11
- **Primary completion:** 2014-09
- **Final completion:** 2014-09
- **Target enrollment:** 119 (ACTUAL)
- **Why stopped:** The study treatment failed to demonstrate efficacy in target population in two other clinical studies (CAFQ056B2214 and CAFQ056A2212).
- **Last updated:** 2016-03-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01433354

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01433354, "Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT01433354. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*