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This study evaluated the safety and effectiveness of a drug called AFQ056 compared with placebo in adolescents with Fragile X syndrome. It enrolled patients 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 * Weigh less than 32 kg * Females who are sexually active Other protocol-defined inclusion/exclusion criteria may apply