Improvement in Functional Impairment During the Early Morning and Late Afternoon/Evening Bookends of the Day: Data from Two Phase 3 Trials of Evening-Dosed Delayed-Release and Extended-Release Methylphenidate in Children with ADHD

Purpose: Evening-dosed HLD200 is a delayed-release and extended-release methylphenidate (DR/ER-MPH) which uses the DELEXIS® drug delivery technology to delay initial drug release by 8–10 hours, providing onset of treatment effect upon awakening and lasting into the evening. Herein, we report clinician-rated assessments of functional impairment based on parent interview during the early morning and late afternoon/evening in children with attention-deficit/hyperactivity disorder (ADHD) from two pivotal, multicenter, phase 3 trials of DR/ER-MPH. Methods: HLD200-107 (NCT02493777) was a placebo-controlled laboratory classroom trial in children (6–12 years) with ADHD. DR/ER-MPH was titrated to …