NCT02457819

Dasotraline Pediatric Extension Study

An Open-label, Flexibly-dosed, 26-Week Extension Safety Study of Dasotraline in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This is an open label 26 week extension study for subjects who completed SEP360-202.

Detailed description

This is an open-label, flexibly-dosed, 26 week extension study in children and adolescents with ADHD who have completed 6 weeks of double-blind treatment in the core study (SEP360 202). This study will evaluate the long-term safety and tolerability of dasotraline in this population.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Dasotraline	Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed

Timeline

• Start date: 2015-06-30
• Primary completion: 2017-02-02
• Completion: 2017-02-02
• First posted: 2015-05-29
• Last updated: 2020-01-28
• Results posted: 2020-01-18

Locations

36 sites across 1 country: United States