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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00443391

Purpose

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

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: ABT-089	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	The Long-Term Safety and Tolerability of ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study

Further study details as provided by Abbott:

Primary Outcome Measures:

CAARS:INV [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AAQoL [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
WPAI [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
RUQ [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
FTND [ Time Frame: Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]

Enrollment:	141
Study Start Date:	February 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-089 Open label study, subjects will take up to 80mg daily for 24 months.

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443391

Sponsors and Collaborators

Abbott

Investigators

Study Director:

George Apostol, MD

Abbott

More Information

Responsible Party:	Abbott ( Laura Gault, MD )
Study ID Numbers:	M06-889
Study First Received:	March 2, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00443391
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

ADHD

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009