A Safety and Tolerability Study of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)

Phase 2

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: ABT-089

• Registration Number: NCT00443391
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with ADHD.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-02
• Study First Posted: 2007-03-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2011-08-18
• Disposition First Submitted QC: 2011-08-18
• Disposition First Posted: 2011-08-23
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
• If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
• If female, the result of a pregnancy tests are negative
• The subject is judged to be in generally good health

Exclusion Criteria

• More than 7 days have elapsed since the last dose of study drug in Study M06-855
• The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
• The subject anticipates a move outside the geographic area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ABT-089	-

Primary Outcome Measures

Name	Time	Method
CAARS:INV	Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S	Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Secondary Outcome Measures

Name	Time	Method
AAQoL	Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
WPAI	Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
RUQ	Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24
FTND	Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Trial Locations

Locations (21)

Site Reference ID/Investigator# 6109; 🇺🇸 Mesa, Arizona, United States

Site Reference ID/Investigator# 6100; 🇺🇸 Lafayette, California, United States

Site Reference ID/Investigator# 6107; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 6105; 🇺🇸 Tampa, Florida, United States

Site Reference ID/Investigator# 6094; 🇺🇸 Smyrna, Georgia, United States

Site Reference ID/Investigator# 6099; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator# 6765; 🇺🇸 Mesa, Arizona, United States

Site Reference ID/Investigator# 6096; 🇺🇸 Maitland, Florida, United States

Site Reference ID/Investigator# 6106; 🇺🇸 Chapel Hill, North Carolina, United States

Site Reference ID/Investigator# 6112; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 6097; 🇺🇸 Charleston, South Carolina, United States

Site Reference ID/Investigator# 6104; 🇺🇸 Lake Jackson, Texas, United States

Site Reference ID/Investigator# 6113; 🇺🇸 Farmington Hills, Michigan, United States

Site Reference ID/Investigator# 6111; 🇺🇸 Newton, Kansas, United States

Site Reference ID/Investigator# 6098; 🇺🇸 Memphis, Tennessee, United States

Site Reference ID/Investigator# 6101; 🇺🇸 Middleton, Wisconsin, United States

Site Reference ID/Investigator# 6110; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 6102; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 6092; 🇺🇸 Seattle, Washington, United States

Site Reference ID/Investigator# 6103; 🇺🇸 Austin, Texas, United States

Site Reference ID/Investigator# 6095; 🇺🇸 Herndon, Virginia, United States