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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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