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

Completed · Phase 2 · Has a placebo group

Conditions studied: Fragile X Syndrome

In brief

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.

Key facts

Study ID

NCT01253629

Run by

Novartis Pharmaceuticals

People needed

175

Starts

2010-11-01

Expected to finish

2013-08-01

Last updated by the study team

2020-12-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Decatur, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Staten Island, New York, United States
• Novartis Investigative Site — Media, Pennsylvania, United States
• Novartis Investigative Site — Greenwood, South Carolina, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Ryde, New South Wales, Australia
• Novartis Investigative Site — Waratah, New South Wales, Australia
• Novartis Investigative Site — Caulfield, Victoria, Australia
• Novartis Investigative Site — Brampton, Ontario, Canada
• Novartis Investigative Site — Sherbrooke, Quebec, Canada
• Novartis Investigative Site — Glostrup Municipality, Denmark
• Novartis Investigative Site — Bron, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Mainz, Germany
• Novartis Investigative Site — Tübingen, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Genova, GE, Italy

Full record on ClinicalTrials.gov

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