Status:
COMPLETED
Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Fragile X Syndrome
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01253629
Start Date
November 1 2010
End Date
August 1 2013
Last Update
December 23 2020
Active Locations (31)
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1
Novartis Investigative Site
Phoenix, Arizona, United States, 85006
2
Novartis Investigative Site
Sacramento, California, United States, 95817
3
Novartis Investigative Site
Decatur, Georgia, United States, 30033
4
Novartis Investigative Site
Chicago, Illinois, United States, 60612