Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome

Stopped early · Phase 2

Conditions studied: Fragile X Syndrome

In brief

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212 (NCT01253629).study and patients who have participated in the previous proof-of-concept study CAFQ056A2204 (NCT00718341).

Key facts

Study ID

NCT01348087

Run by

Novartis Pharmaceuticals

People needed

148

Starts

2011-08-01

Expected to finish

2014-09-01

Last updated by the study team

2016-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any advanced, severe or unstable disease
• History of severe self- injurious behavior
• History of uncontrolled seizure disorder or resistant to therapy within the past 2 years (Patients who are clinically stable under anti-convulsant therapy for the past 2 years are not excluded)
• History of clinically significant allergies requiring hospitalization or non- inhaled corticosteroid therapy (asthma, anaphylaxis, etc.)
• Using (or used within 6 weeks before baseline) concomitant medications that are potent inhibitors or inducers of CYP3A4
• Using glutamatergic agents (riluzole, memantine, etc.) or lithium, digoxin, or warfarin within 6 weeks of baseline 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 — Nashville, Tennessee, 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, Germany
• Novartis Investigative Site — Mainz, Germany, Germany
• Novartis Investigative Site — Tübingen, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Genova, GE, Italy
• Novartis Investigative Site — Málaga, Andalusia, Spain
• Novartis Investigative Site — Sant Cugat del Vallès, Catalonia, Spain

Full record on ClinicalTrials.gov

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