A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN 812 in Preschool-Age Children (4 to 5 years old) with Attention-Deficit/Hyperactivity Disorder (ADHD)

Description:  This research study is being conducted to evaluate the efficacy of SPN-812 100mg compared to placebo on ADHD symptoms in preschool-age children with DSM-IV-TR. Eligibility includes, but is not limited to children ages 4yrs 0 months and 5yrs 9 months with a primary diagnosis of ADHD (children in the process of being diagnosed can also qualify), is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school or childcare program). The study duration is 10 weeks which consists of 8 onsite visits and includes ECGs and laboratory tests.