For a phase II trial, investigators tested a transdermal therapy among 110 children and adolescents with ADHD not adequately controlled with current medication. During an open-label, dose-optimization period, participants place a 5 mg patch on the hip for 9 hours on alternating sides every day, adjust the dose as needed at weekly clinic visits over the following 5 weeks. Optimal doses per 9 hours of 15 mg, 10 mg, 20 mg, and 5 mg were achieved by 39%, 33%, 21%, and 7% of participants, respectively. Participants continued on their optimal dose or placebo for another 2 weeks. Benefits were observed as soon as 2 hours after dosing and maintained for 12 hours in a laboratory classroom setting; SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) total scores at baseline were 14.9 in the treatment group and 13.0 in the placebo group, increasing to 15.7 and 21.5, respectively, after 12 hours. While 96% of patients reported treatment-emergent adverse events, most were mild to moderate, and although 25% experienced an application-site reaction, none led to discontinuation and most resolved within a few hours.
