A randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Ritalin� LA in adult patients with childhood-onset ADHD
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Last updated:17th Nov 2010
Main objectives of the trial are; To confirm the clinically effective dose range of Ritalin LA in adults with childhood onset ADHD as measured by the change from Baseline to the end of a 9-week, fixed-dose treatment period in DSM-IV Attention-Deficit/Hyperactive Disorder Rating Scale (DSM-IV ADHD RS) total score. To evaluate improvement in functional impairment will be measured by the change from baseline in total score on the Sheehan Disability (SDS) is a self-rating scale designed to assess the functional impairment of patients with ADHD at the end of a 9-week fixed-dose treatment period. To evaluate the maintenance of effect of Ritalin LA in adults with childhood onset ADHD as measured by the percentage of Ritalin LA vs. placebo treatment failures at the end of a 6-month treatment withdrawal period. To evaluate the safety of Ritalin LA in adults with childhood onset ADHD as measured by the frequency of AEs, the results of laboratory tests, and the measurement of vital signs and ECGs.
|Study start date||2010-11-17|