Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)
Public ClinicalTrials.gov record NCT01433354. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Study to Evaluate the Long-term Safety and Tolerability of AFQ056 in Adolescent Patients With Fragile X Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.
Study identification
- NCT ID
- NCT01433354
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 119 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2011 (Type not available)
- Primary completion
- Sep 2014 (Actual)
- Completion
- Sep 2014 (Actual)
- Last update posted
- Mar 24, 2016
2011 – 2014
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Sacramento | California | 95817 | — |
| Novartis Investigative Site | Decatur | Georgia | 30033 | — |
| Novartis Investigative Site | Chicago | Illinois | 60612 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68198-5575 | — |
| Novartis Investigative Site | Staten Island | New York | 10314 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37212 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01433354, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2016 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01433354 live on ClinicalTrials.gov.