A 6-month, open-label, extension study of the tolerability and effectiveness of the methylphenidate transdermal system in adolescents diagnosed with attention-deficit/hyperactivity disorder

Objective: The aim of this study was to evaluate the tolerability and effectiveness of the methylphenidate transdermal system (MTS) over 6 months in adolescents with attention-deficit/hyperactivity disorder (ADHD). Methods: This was an industry-sponsored, 30-center, open-label study of subjects aged 13-17 years with ADHD. Subjects were dose-optimized with MTS (10-30mg/9 hours) over 5 weeks and then dose-maintained for up to 5 months. Tolerability evaluations included treatment-emergent adverse events (TEAEs) and dermal responses. Effectiveness was assessed with the ADHD-Rating Scale-IV (ADHD-RS-IV). Results: A total of 162 subjects received MTS treatment. The majority of TEAEs (>99%) were mild or moderate in intensity, and the most frequently reported TEAE was decreased appetite (15.4%). Thirteen subjects discontinued the study due to TEAEs. The majority (93.6%) of dermatologic reactions indicated mild erythema. There was significant improvement in mean ADHD-RS-IV total scores from study entry to end point (p<0.001). Conclusion: Slightly more than half (54.0%) of subjects completed this 6-month, open-label extension study of MTS; the primary reason for discontinuation was withdrawn consent (36.0%). Reported TEAEs and skin tolerability findings were similar to those observed with MTS use in children and adolescents. MTS treatment resulted in a decrease in ADHD symptoms as rated by clinicians. NIH Clinical Trials Registry: # NCT00501293