A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.

Phase 3 Completed 95 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.

Timeline

Start: 2017-07-31
Primary completion: 2019-03-15
Completion: 2019-03-15

Outcome

Met primary endpoint

paper Treatment with dasotraline was associated with significant improvement versus placebo in the primary SKAMP-combined score PMID 35048745 ↗

registry Placebo vs Dasotraline; p <0.001; Mean Difference (Final Values) -5.24 (95% CI -7.351 to -3.137) NCT03231800 ↗

Publications

Wigal S, Tsai J, Bates JA, Sarma K, Tortorich D, Zhu H, Goldman R. A Randomized, Placebo-Controlled Laboratory Classroom Study of the Efficacy and Safety of Dasotraline in Children With ADHD. J Atten Disord. 2022 Aug;26(10):1357-1368. doi: 10.1177/10870547211073477. Epub 2022 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dasotraline	Small molecule	2 mg	—