Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome
NCT ID: NCT01253629
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2010-11-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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25 mg bid AFQ056
1 capsule of 25 mg and 1 capsule of placebo per intake
AFQ056
AFQ056, was provided as hard gelatin capsules, 25mg and 100 mg oral dosage strengths, identical in appearance were used
50 mg bid AFQ056
2 capsules of 25 mg per intake
AFQ056
AFQ056, was provided as hard gelatin capsules, 25mg and 100 mg oral dosage strengths, identical in appearance were used
100 mg bid AFQ056
1 capsule of 100 mg and 1 capsule of placebo per intake
AFQ056
AFQ056, was provided as hard gelatin capsules, 25mg and 100 mg oral dosage strengths, identical in appearance were used
Placebo
2 capsules of placebo per intake
Placebo
Placebo medication identical in appearance to active medication was provided
Interventions
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AFQ056
AFQ056, was provided as hard gelatin capsules, 25mg and 100 mg oral dosage strengths, identical in appearance were used
Placebo
Placebo medication identical in appearance to active medication was provided
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
45 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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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
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Würzburg, , Germany
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, Spain
Novartis Investigative Site
Lausanne, , Switzerland
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigative Site
Edinburgh, , United Kingdom
Countries
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References
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Berry-Kravis E, Des Portes V, Hagerman R, Jacquemont S, Charles P, Visootsak J, Brinkman M, Rerat K, Koumaras B, Zhu L, Barth GM, Jaecklin T, Apostol G, von Raison F. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials. Sci Transl Med. 2016 Jan 13;8(321):321ra5. doi: 10.1126/scitranslmed.aab4109.
Related Links
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Results for CAFQ056A2212 from the Novartis Clinical Trial website
Other Identifiers
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2009-013667-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAFQ056A2212
Identifier Type: -
Identifier Source: org_study_id