NCT02276209

Dasotraline Adult ADHD Study

A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 636 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD.

Detailed description

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD using 2 doses of dasotraline (4 mg/day or 6 mg/day) versus placebo over an 8 week treatment period (8 weeks of active treatment followed by a 2-week withdrawal phase).

Conditions

• Adult Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Dasotraline	Dasotraline 4 mg once daily
DRUG	Dasotraline	Dasotraline 6 mg once daily
OTHER	Placebo	Placebo once daily

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-10-28
• Last updated: 2017-08-28

Locations

59 sites across 1 country: United States