Efficacy and Safety of Ritalin® LA™, a New, Once Daily, Extended-Release Dosage Form of Methylphenidate, in Children with Attention Deficit Hyperactivity Disorder

Objective: To evaluate the safety and efficacy of extended-release methylphenidate with a bimodal profile using SODAS™ technology (Ritalin® LA™) compared with placebo in children aged 6-14 years with attention deficit hyperactivity disorder (ADHD). Method: This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in children meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD. Following titration and a 1-week placebo washout period, patients were randomized to 2 weeks of double-blind treatment with either Ritalin® LA™ (10-40 mg/day) or placebo. The efficacy assessments used were the Conners' ADHD/ DSM-IV Scales for teachers (CADS-T) and for parents (CADS-P), and the Clinical Global Impression-Improvement Scale (CGI-I) completed by the investigator. The primary efficacy variable was the change from baseline (end of placebo washout) to the final rating (end of 2-week double-blind treatment) in the CADS-T Total subscale score. Results: One-hundred-and-sixty-one children were treated and 134 responders were included in the intent-to-treat analysis. Ritalin® LA™ achieved a mean change from baseline (± SD) on the CADS-T Total subscale of -10.7 (±15.68) compared with 2.8 (±10.59) for placebo (p < 0.0001); the effect size on the CADS-T Total score with Ritalin® LA™ was 0.90. Additionally, 69.8% of patients in the Ritalin® LA™ group were rated as much or very much improved on the CGI-I at final assessment compared with 40% of patients in the placebo group (p = 0.0009). The adverse events reported were generally mild or moderate, and were similar in both groups. Conclusion: The results demonstrate that Ritalin® LA™ administered once daily for up to 2 weeks achieved outcomes statistically superior to placebo in children with ADHD.