NCT02160262

Open-label Safety Study in Adults With ADHD

A Phase 3, 12-Month, Multicenter, Open-label, Flexibly-dosed, Safety Study of SEP 225289 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 724 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with Attention Deficit Hyperactivity Disorder (ADHD)

Detailed description

To evaluate the long-term safety and tolerability of SEP 225289 in adult subjects with ADHD by the incidence of adverse events (AEs; or serious AEs), AEs (or SAEs) leading to discontinuation

Conditions

• Adult Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Dasotraline	Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed, once daily

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-06-10
• Last updated: 2017-05-02

Locations

65 sites across 1 country: United States