Serdexmethylphenidate/Dexmethylphenidate for Children With Attention-Deficit Hyperactivity Disorder: Reduction in Disorder Severity From a Laboratory Classroom Study

Abstract: Aim: To evaluate changes in attention-deficit hyperactivity disorder (ADHD) severity in children (aged 6-12 years) posttreatment with serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) in a laboratory classroom setting. Methods: During a 3-week open-label, dose-optimization phase, subjects (Nf150) were titrated to a final SDX/d-MPH dose of 26.1/5.2 mg, 39.2/7.8 mg, or 52.3/10.4 mg based on tolerability and best individual response. During the subsequent 7-day double-blinded treatment period, subjects received once-daily SDX/d-MPH or placebo. The primary efficacy end point was mean change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham-Combined (SKAMP-C) scores averaged over the laboratory classroom day (0.5-13 h postdose). The Conners 3rd Edition-Parent (C3P) score, an exploratory end point, assessed weekly changes in ADHD severity during the dose-optimization and treatment phases. Results: During the treatment phase, SKAMP-C scores improved significantly with SDX/d-MPH vs placebo (least-squares mean treatment difference [95% CI], −5.4 [−7.1, −3.7]; PShort Description: The aim of this study was to evaluate changes in attention-deficit hyperactivity disorder (ADHD) severity in children (aged 6-12 years) posttreatment with serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) in a laboratory classroom setting. The Conners 3rd Edition-Parent (C3P) score, an exploratory end point of this classroom study, assessed weekly changes in ADHD severity during dose-optimization and treatment phases in the study. Our findings show that SDX/d-MPH demonstrated significant reductions in ADHD severity in children based on the C3P scores.Name of Sponsoring Organization(s): KemPharm, Inc.