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Published on: June 12, 2020
A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system
James J McGough1, Sharon B Wigal, Howard Abikoff
1University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior, 90095, USA. jmcgough@mednet.ucla.edu
Objective:
This study evaluates the efficacy, duration of action, and tolerability of methylphenidate transdermal system (MTS) in children with ADHD.
Method:
Participants were dose optimized over 5 weeks utilizing patch doses of 10, 16, 20, and 27 mg applied in the morning and worn for 9 hours. Following optimization, 80 participants were randomized to 1 week of MTS or placebo followed by 1 week of the opposite treatment. Laboratory classroom sessions conducted after each randomized week included blinded ratings of attention, behavior, and academic performance.
Results:
MTS was well tolerated and displayed significant improvement compared with placebo. Improvements were seen at the first postdose time point measured and continued through 12 hours.
Conclusions:
Treatment with MTS resulted in statistically significant improvements on all efficacy measures. Time course and therapeutic effects of MTS suggest that this novel methylphenidate delivery system is an efficacious once-daily treatment for ADHD.
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