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This Phase 2 study evaluates the safety and effectiveness of the experimental drug AFQ056, compared with placebo, in adult patients with Fragile X syndrome. It included adults with Fragile X syndrome who were at least moderately affected and met certain assessment criteria. It was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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 Other protocol-defined inclusion/exclusion criteria may apply