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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443391
• Other study ID #: M06-889
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2007
• Last updated: January 10, 2013
• Start date: February 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• ABT-089
Open label study, subjects will take up to 80mg daily for 24 months.

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 6103	Austin	Texas
United States	Site Reference ID/Investigator# 6106	Chapel Hill	North Carolina
United States	Site Reference ID/Investigator# 6097	Charleston	South Carolina
United States	Site Reference ID/Investigator# 6113	Farmington Hills	Michigan
United States	Site Reference ID/Investigator# 6095	Herndon	Virginia
United States	Site Reference ID/Investigator# 6112	Jacksonville	Florida
United States	Site Reference ID/Investigator# 6100	Lafayette	California
United States	Site Reference ID/Investigator# 6104	Lake Jackson	Texas
United States	Site Reference ID/Investigator# 6096	Maitland	Florida
United States	Site Reference ID/Investigator# 6098	Memphis	Tennessee
United States	Site Reference ID/Investigator# 6109	Mesa	Arizona
United States	Site Reference ID/Investigator# 6765	Mesa	Arizona
United States	Site Reference ID/Investigator# 6101	Middleton	Wisconsin
United States	Site Reference ID/Investigator# 6099	New York	New York
United States	Site Reference ID/Investigator# 6111	Newton	Kansas
United States	Site Reference ID/Investigator# 6110	Omaha	Nebraska
United States	Site Reference ID/Investigator# 6102	Portland	Oregon
United States	Site Reference ID/Investigator# 6107	San Diego	California
United States	Site Reference ID/Investigator# 6092	Seattle	Washington
United States	Site Reference ID/Investigator# 6094	Smyrna	Georgia
United States	Site Reference ID/Investigator# 6105	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAARS:INV		Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24	No
Primary	CGI-ADHD-S		Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	AAQoL		Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	WPAI		Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	RUQ		Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24	No
Secondary	FTND		Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24	No