Update on a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating SPN-810 for the Treatment of Impulsive Aggression (IA) in Pediatric Patients with ADHD

Background: Aggression is one of the most common reasons for psychiatric referral in children. The most prevalent subtype of maladaptive aggression is IA – which is reactive, overt, and occurs outside the social context. IA is a serious health concern, occurring across multiple neuropsychiatric disorders, including ADHD. There is no treatment specifically indicated for IA, and in patients with both IA and ADHD, treatment with ADHD medication only marginally improves aggressive behavior (~26% of patients remain symptomatic). Here we describe an ongoing Phase 3 study investigating the safety and efficacy of extended-release molindone (SPN-810) for treatment of IA in children with ADHD.

Methods: This is a randomized, double-blind, placebo-controlled study evaluating SPN-810 for the treatment of IA in children ages 6–12 with ADHD. Among the inclusion criteria are: ADHD diagnosis, use of FDA-approved ADHD medication, and signs of IA (measured by the R-MOAS and Aggression Questionnaire). Subjects are randomized to SPN-810 treatment or placebo for the 5-week treatment phase (2-week titration/3-week maintenance). The primary efficacy measure is the frequency of IA behavior collected via a novel assessment tool, the IA diary; secondary efficacy measures are evaluated based on established clinical rating scales. Safety assessments include monitoring adverse events and emergence of extrapyramidal symptoms, and evaluating clinical laboratory test results, ECGs, vital signs, and the C-SSRS.

Results: As of August 2018, ~91% of planned subjects have been enrolled.

Summary: The SPN 810 Phase 3 program is progressing and topline results of this study are forthcoming.