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NCT01253629 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
NCT01253629: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01253629 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 175 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01253629, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 175 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 ABC-C is a 58-item questionnaire that should have been completed as much as possible by the same rater. It is comprised of five subscales (irritability, lethargy/social withdrawal, stereotypic behavior, hyperactivity and inappropriate speech) plus the total score which ranks from 0 to 174 in patients who were fully methylated (FM)
Interventions
- DRUG Placebo
- DRUG AFQ056
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01253629 record still lists
NCT01253629 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01253629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01253629 about?
NCT01253629 is a clinical study titled "Safety and Efficacy of AFQ056 in Adult 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 NCT01253629?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2010-11. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01253629?
The interventions under investigation include: Placebo (DRUG), AFQ056 (DRUG).
Who is sponsoring clinical trial NCT01253629?
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 NCT01253629's enrollment target sits among peer trials
175 396th of 2000 higher than 1,605 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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