(#3) Effect of Centanafadine on the AIM-A After 6 Weeks of Treatment in Adults with ADHD: A Pooled Analysis of Two Phase 3 Trials

Abstract: Objective: ADHD is a chronic and prevalent neurodevelopmental disorder in adults, characterized by symptoms of inattention, hyperactivity, and impulsivity. This pooled analysis of 2 phase 3 trials evaluated the effect of centanafadine (CTN)óa norepinephrine, dopamine, serotonin reuptake inhibitoróon the quality of life (QoL) of adults with ADHD. Methods: Data from 2 identically designed phase 3 trials were pooled. Eligible patients aged 18-55 years with a primary ADHD diagnosis per DSM-5 were randomized to receive CTN 200 or 400mg/day or placebo. Exploratory endpoints included change from baseline in ADHD Impact Module-Adult (AIM-A), a self-reported QoL assessment, at Week 6. Endpoints were analyzed using a mixed-effects model for repeated measure without adjusting for multiplicity and are therefore descriptive. Results: Overall, 859 adults (mean age 35y, 52% male) were randomized to CTN 200mg (n=287), CTN 400mg (n=287), or placebo (n=285). CTN demonstrated clinically meaningful improvement on the AIM-A multi-item summary scores vs placebo. For CTN 200 and 400mg, the treatment difference vs placebo in summary scores of Living With ADHD was 4.43 and 3.79 (both P