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NCT01357239 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
NCT01357239: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01357239 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 139 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01357239, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
Study Summary
This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.
Primary Outcome
The Aberrant Behavior Checklist-Community edition (ABC-C) is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 ("not at all a problem") to 3 ("problem is severe in degree") and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the mod
Interventions
- DRUG Placebo
- DRUG AFQ056
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT01357239 record still lists
NCT01357239 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01357239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01357239 about?
NCT01357239 is a clinical study titled "Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome". This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.
What is the current status of trial NCT01357239?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2011-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01357239?
The interventions under investigation include: Placebo (DRUG), AFQ056 (DRUG).
Who is sponsoring clinical trial NCT01357239?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01357239's enrollment target sits among peer trials
139 525th of 2000 higher than 1,476 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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