Zusammenfassung
Objectives: The primary objective of this study was to demonstrate efficacy of Ritalin (R) LA 20 mg by showing superiority to placebo and noninferiority to Medikinet (R) 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 ...
Zusammenfassung
Objectives: The primary objective of this study was to demonstrate efficacy of Ritalin (R) LA 20 mg by showing superiority to placebo and noninferiority to Medikinet (R) 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 (R) LA demonstrated superiority compared to placebo (p< 0.0001). The observed difference in the SKAMP scores between Ritalin (R) LA and Medikinet (R) 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 (R) LA is an efficacious, well-tolerated treatment option for children aged 6-14 with ADHD.
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