Long Term 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: NCT00686933
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-30
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Disposition First Submitted: 2011-08-19
• Disposition First Submitted QC: 2011-08-19
• Disposition First Posted: 2011-08-23
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• The subject was randomized into Study M10-346 and completed the study.
• Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
• Male subjects must agree to comply with applicable contraceptive requirements.
• The subject is judged to be in generally good health.

Exclusion Criteria

• The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 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, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CGI-ADHD-S	Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24

Secondary Outcome Measures

Name	Time	Method
FTND	Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
CAARS:Self	Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24
BRIEF-A	Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
AAQOL	Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24
WPAI	Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24

Trial Locations

Locations (12)

Site Reference ID/Investigator# 8319; 🇺🇸 Virginia Beach, Virginia, United States

Site Reference ID/Investigator# 8318; 🇺🇸 Troy, Michigan, United States

Site Reference ID/Investigator# 8310; 🇺🇸 Memphis, Tennessee, United States

Site Reference ID/Investigator# 8309; 🇺🇸 Eugene, Oregon, United States

Site Reference ID/Investigator# 8315; 🇺🇸 Lafayette, California, United States

Site Reference ID/Investigator# 8306; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 8308; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 8314; 🇺🇸 Overland Park, Kansas, United States

Site Reference ID/Investigator# 8307; 🇺🇸 Farmington Hills, Michigan, United States

Site Reference ID/Investigator# 8320; 🇺🇸 Seattle, Washington, United States

Site Reference ID/Investigator# 8316; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 8305; 🇺🇸 Bellevue, Washington, United States