Safety and Efficacy of AFQ056 in Adolescent 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

NCT01357239

Run by

Novartis Pharmaceuticals

People needed

139

Starts

2011-05-01

Expected to finish

2014-01-01

Last updated by the study team

2015-05-12

Who can join

Age: 12 and older, up to 17. 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
• Weigh less than 32 kg
• Females who are sexually active
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Decatur, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, 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 — Nashville, Tennessee, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Glostrup Municipality, Denmark
• Novartis Investigative Site — Bron, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Mainz, Germany, Germany
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Tübingen, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Semarang, Central Java, Indonesia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.