A Phase III Study of HLD200 in Children with Attention-Deficit/Hyperactivity Disorder: Safety Results

Purpose: This exploratory study consisted of a 6-week open-label, treatment optimization phase followed by a 1-week randomized, double-blind, placebo-controlled, parallel-group test phase to assess HLD200, a delayed- and extended-release formulation of methylphenidate (MPH) designed to be taken in the evening, before bedtime to control early morning attention-deficit/hyperactivity disorder (ADHD) symptoms before school and throughout the day, in pediatric subjects. Methods: Males and females with ADHD, ages 6-12 were enrolled. At baseline (visit 2 [V2]), subjects initiated HLD200 at their previous MPH dose equivalent for 1 week and were dose optimized …