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

No publications provided

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 History of Changes
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:

Signs and Symptoms
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases

Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on May 07, 2009