A Randomized, Placebo-Controlled Laboratory Classroom Study of the Efficacy and Safety of Dasotraline in Children With ADHD.

OBJECTIVE: To evaluate the efficacy of dasotraline 2 mg/day for treatment of ADHD in children weighing ≤30 kg. METHOD: Children (ages 6-12) with ADHD were randomized to 14 days of once-daily evening doses of dasotraline 2 mg (n = 47) or placebo (n = 48). Efficacy was assessed at Baseline and day-15 in seven, 30-minutes classroom sessions on each day (8:00 a.m. to 8:00 p.m.; 12-24 hours post-dose). The primary endpoint was change from Baseline at Day-15 in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) combined score averaged over the seven, serial timepoints. RESULTS: Treatment with dasotraline was associated with significant improvement versus placebo in the primary SKAMP-combined score (least squares mean [SE] change from Baseline at Day-15: -3.67 [0.775] vs. +1.57 [0.773]; p < .001; effect size, 1.04). CONCLUSION: Dasotraline 2 mg/day was found to be efficacious and generally well tolerated in this placebo-controlled, laboratory classroom study of children ages 6 to 12 years with ADHD. CLINICALTRIALS.GOV IDENTIFIER: NCT03231800.