NCT01692782

Adult Attention Deficit Hyperactivity Disorder

A Randomized, Double Blind, Parallel Group, Multicenter Efficacy and Safety Study of SEP-225289 Versus Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD).

Detailed description

This is a Phase 2, randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of SEP 225289 in adults with ADHD using 2 oral dosages (4 or 8 mg SEP 225289 once daily \[QD\]) versus placebo over a 4 week treatment period.

Conditions

• Adult Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	SEP-225289	SEP-225289 4mg once daily
DRUG	SEP-225289	SEP-225289 8mg once daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2012-09-25
• Last updated: 2015-01-12
• Results posted: 2015-01-12

Locations

31 sites across 1 country: United States