Long Term 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:	NCT00686933

Purpose

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).

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

CAARS:Self [ Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
BRIEF-A [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
AAQOL [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
WPAI [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
FTND [ Time Frame: Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]

Enrollment:	117
Study Start Date:	May 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-089 Subjects will take up to 80 mg daily for 24 months

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686933

Locations

United States, California

Lafayette, California, United States, 94549
United States, Florida

Orlando, Florida, United States, 32806

Jacksonville, Florida, United States, 32216
United States, Kansas

Overland Park, Kansas, United States, 66212
United States, Michigan

Farmington Hills, Michigan, United States, 48336

Troy, Michigan, United States, 48085
United States, Oregon

Eugene, Oregon, United States, 97401

Portland, Oregon, United States, 97210
United States, Tennessee

Memphis, Tennessee, United States, 38119
United States, Virginia

Virginia Beach, Virginia, United States, 23452
United States, Washington

Bellevue, Washington, United States, 98004

Seattle, Washington, United States, 98104

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Earle Bain, MD

Abbott

More Information

Responsible Party:	Abbott ( Earle Bain, MD )
Study ID Numbers:	M10-425
Study First Received:	May 28, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00686933
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Attention-Deficit/Hyperactivity Disorder

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