Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:12 - 17
Updated:5/5/2014
Start Date:May 2011
End Date:January 2014
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety 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.


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

- Weigh less than 32 kg

- Females who are sexually active

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
15
sites
Novartis Investigative Site
Houston, Texas 77030
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Novartis Investigative site
Aurora, Colorado 80010
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Aurora, CO
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Novartis Investigative Site
Bellevue, Washington 98004
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Bellevue, WA
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Novartis Investigative site
Boston, Massachusetts 02118
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Boston, MA
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Novartis Investigator Site
Chicago, Illinois 60612
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Chicago, IL
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Novartis Investigative site
Dallas, Texas 75216
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Dallas, TX
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Novartis Investigative Site
Decatur, Georgia 30030
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Decatur, GA
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Novartis Investigative Site
Greenwood, South Carolina 29646
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Greenwood, SC
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Novartis Investigative Site
Indianapolis, Indiana 46202
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Indianapolis, IN
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Novartis Investigative Site
Nashville, Tennessee 37205
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Nashville, TN
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Novartis Investigative Site
Omaha, Nebraska 68144
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Omaha, NE
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Novartis Investigative Site
Sacramento, California 95825
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Sacramento, CA
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Novartis Investigative Site
Seattle, Washington 98103
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Seattle, WA
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Novartis Investigative Site
Springfield, Massachusetts 01104
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Springfield, MA
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Novartis Investigative Site
Staten Island, New York 10312
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Staten Island, NY
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