Dasotraline Efficacy Throughout the Day in Children With Attention-Deficit/Hyperactivity Disorder: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in a Laboratory Classroom Setting
This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
Objectives: Once-daily dosing with dasotraline, a novel dopamine and norepinephrine reuptake inhibitor, achieves stable plasma concentrations over 24 hours. This study evaluated the efficacy and safety of dasotraline in children with ADHD, in a laboratory classroom setting.
Methods: Children (6-12 years) meeting DSM-5 criteria for ADHD were randomized to 2 weeks of dasotraline or placebo (dosed daily at home at ~8PM). Laboratory classroom evaluations took place at baseline and Day 15. The primary endpoint was change from baseline at Day 15 in ADHD symptoms, as measured by mean SKAMP-Combined Score, derived from 7 assessments across the 12-hour laboratory classroom day (12-24 hours post-dose). Secondary endpoints included SKAMP scores at timepoints from 8AM through 8PM, and measures of safety.
Results: The ITT population comprised 112 patients. Mean age was 9.5 years; 68.8% were male; 92% completed the study. Dasotraline 4 mg/day significantly improved mean SKAMP-CS versus placebo (p<0.0001, effect size 0.85) with significant effects persisting throughout the day. Mean SKAMP subscores improved significantly versus placebo (Attention p<0.0001, effect size 0.81; Deportment p<0.001, effect size 0.70). TEAEs were mild or moderate in severity; most frequent were (dasotraline 4 mg/day; placebo): insomnia (19.6%; 3.6%, all terms combined), decreased appetite (10.7%; 3.6%), headache (10.7%; 8.9%), affect lability (8.9%; 7.1%), irritability (5.4%; 3.6%), and perceptual disturbances (5.4%; 0%).
Conclusions: In this laboratory classroom study in children with ADHD, dasotraline significantly improved ADHD symptoms compared with placebo, and demonstrated sustained efficacy up to 24 hours post-dose. Most common TEAEs were insomnia, decreased appetite, and headache.