6.51 ACHIEVEMENT AND MAINTENANCE OF NORMALIZED LEVELS OF EARLY MORNING AND LATE AFTERNOON/EVENING FUNCTIONAL IMPAIRMENT WITH DELAYED-RELEASE AND EXTENDED-RELEASE METHYLPHENIDATE (DR/ER-MPH) IN CHILDREN WITH ADHD: POST HOC ANALYSES OF BEFORE-SCHOOL FUNCTIONING

Abstract

In a pivotal phase 3 trial in children (ages 6–12 years) with ADHD, 1 week of double-blind (DB) treatment with evening-dosed HLD200, a delayed-release and extended-release methylphenidate (DR/ER-MPH), resulted in significant improvements in early morning and late afternoon/evening functional impairment versus placebo (PBO), as measured by the validated Parent Rating of Evening and Morning Behavior Scale–Revised (PREMB-R), morning (AM) and evening (PM) subscales, respectively. Substantial improvements in functional impairment over the preceding 6-week, open-label (OL) treatment-optimization phase also were noted by PREMB-R AM/PM and the validated Before School Functioning Questionnaire (BSFQ). In this post hoc analysis, age-adjusted, norm-referenced cutoffs, determined from a representative sample group of 1200 US youth (ages 6–17 years), were applied to BSFQ, PREMB-R AM, and PREMB-R PM scores to interpret changes in functional impairment severity levels (screening risk: mild, moderate, and severe) following OL and DB phases of the pivotal phase 3 trial (ClinicalTrial NCT02493777).