NCT02428088

Dasotraline Pediatric ADHD Study

A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.

Detailed description

This is a randomized, double blind, multicenter, placebo-controlled, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in subjects 6 to 12 years of age with ADHD using 2 doses of dasotraline (2 mg/day and 4 mg/day) versus placebo over a 6 week treatment period. The study will consist of screening, treatment, and end of study visits.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Dasotraline	Dasotraline 2 mg once daily
DRUG	Dasotraline	Dasotraline 4 mg once daily
DRUG	Placebo Comparator	Placebo once daily

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-04-28
• Last updated: 2021-03-18

Locations

43 sites across 1 country: United States