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A Double-Blind, Randomized, Placebo/Active Controlled Crossover Evaluation of the Efficacy and Safety of Ritalin ® LA in Children with Attention-Deficit/Hyperactivity Disorder in a Laboratory Classroom Setting

2010; Mary Ann Liebert, Inc.; Volume: 20; Issue: 5 Linguagem: Inglês

10.1089/cap.2009.0106

1557-8992

Eberhard Schulz, Christian Fleischhaker, Klaus Hennighausen, Philip Heiser, Klaus-Uwe Oehler, Martin Linder, Frank Haessler, Michael Huß, Andreas Warnke, Martin H. Schmidt, Michael Schulte-Markworth, Christian Sieder, Jan Klatt, Ferenc Tracik,

Autism Spectrum Disorder Research

Objectives: The primary objective of this study was to demonstrate efficacy of Ritalin® LA 20 mg by showing superiority to placebo and noninferiority to Medikinet® Retard in a laboratory classroom setting. Secondary objectives included safety/tolerability and further efficacy parameters. Methods: A total of 147 children with attention-deficit/hyperactivity disorder (ADHD) diagnosed by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) and aged 6–14 (81% males) and known to be methylphenidate (MPH) responders were enrolled in this multicenter, double-blind, randomized, placebo/active-controlled, three-period (7 days each) crossover study. The Swanson, Kotlin, Agler, M-Flynn, and Pelham (SKAMP) scale was used for efficacy ratings. The mean of SKAMP Combined ratings performed at 10:30 a.m., at 12:00 a.m., and at 1:30 p.m. was defined as the primary parameter. Results: In all, 146 patients completed all treatment periods. Intensity and frequency of adverse events were comparable between the two formulations. Ritalin® LA demonstrated superiority compared to placebo (p < 0.0001). The observed difference in the SKAMP scores between Ritalin® LA and Medikinet® Retard between the hours 1.5 until 4.5 did not exceed the noninferiority margin (p = 0.0003); therefore, the difference is regarded as not clinically relevant. Similar results were obtained for the secondary efficacy variables. Conclusion: Ritalin® LA is an efficacious, well-tolerated treatment option for children aged 6–14 with ADHD.