Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 5/27/2013 |
| Start Date: | November 2010 |
| End Date: | December 2013 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1(862)778-8300 |
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate 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.
Inclusion Criteria:
- Patients with Fragile X Syndrome, who are at least moderately ill based on a Clinical
Global Impression Severity score of at least 4 and have qualifying scores on the
ABC-C and IQ test at Visit 1
Exclusion Criteria:
- Advanced, severe or unstable disease that may interfere with the study outcome
evaluations
- Cancer within the past 5 years, other than localized skin cancer
- Current treatment with more than two psychoactive medications, excluding
anti-epileptics
- History of severe self-injurious behavior
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
13
sites
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