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.

Summary

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

Timeline

Start

2016-04-30

Primary completion

2017-02-28

Completion

2017-02-28

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Dasotraline 4mg; p <0.001; Mean Difference (Final Values) -5.18 (95% CI -7.565 to -2.802); ANCOVA NCT02734693 ↗

release “children ages 6 to 12 years with attention deficit hyperactivity disorder (ADHD). The study met its primary endpoint.” sumitomo-pharma.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dasotraline	Small molecule	4 mg	—

Indications