IngentaConnect Efficacy and Safety of Ritalin LA, a New, Once Daily, Extended-Re...

Abstract:

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.

Keywords: Adolescents; Children; Methylphenidate, therapeutic use; Attention deficit hyperactivity disorder, treatmen

Document Type: Research article

Affiliations: 1: 1 Massachusetts General Hospital, Boston, Massachusetts, USA 2: 2 Royal University Hospital, Saskatoon, Saskatchewan, Canada 3: 3 Children and Women’s Health Centre of British Columbia, Vancouver, British Columbia, Canada 4: 4 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA 5: 5 Novartis Pharma AG, Basel, Switzerland 6: 6 University of California, Irvine, California, USA

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

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