A Randomized, Placebo-Controlled Laboratory Classroom Study of the Efficacy and Safety of Dasotraline in Children With ADHD. Issue 10 (August 2022)

• Record Type: Journal Article
• Authors: Wigal, Sharon; Tsai, Joyce; Bates, John A.; Sarma, Kaushik; Tortorich, Deidre; Zhu, Haiyuan; Goldman, Robert
• Is Part Of: Journal of attention disorders. Volume 26:Issue 10(2022)
• Page Start: 1357
• Page End: 1368
• Publication Date: 2022-08
• Subjects: ADHD -- dasotraline -- randomized controlled trial -- children; Attention-deficit hyperactivity disorder -- Periodicals; Attention -- Periodicals; 616.8589
• DOI: 10.1177/10870547211073477
• Languages: English
• ISSNs: 1087-0547

Abstract

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.