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

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	—

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.

Summary

Timeline

Publications

Drugs

Indications