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

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

sites

Novartis Investigative site

Dallas, Texas 75216

from

Dallas, TX