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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00640419

Purpose

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Further study details as provided by Abbott:

Primary Outcome Measures:

ADHD-RS-IV (HV) [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 ] [ Designated as safety issue: No ]
CGI-ADHD-S [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CSHQ [ Time Frame: Day-1, Day 28, Day 42 ] [ Designated as safety issue: No ]
CGI-P [ Time Frame: Day -1, Day 21, Day 42 ] [ Designated as safety issue: No ]
BRIEF [ Time Frame: Day -1, Day 28, Day 42 ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	March 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-089 Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
2: Experimental	Drug: ABT-089 Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
3: Placebo Comparator	Drug: placebo Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have voluntarily signed an informed consent form.
Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with parent(s).
Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
Subject weights at least 37 pounds (17 kg)
Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria:

Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind.
Subject has a history of, or ongoing, serious medical problem.
Subject has a history of significant allergic reaction to any drug.
Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
Subject requires ongoing treatment with any psychiatric medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640419

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, Florida

Orlando, Florida, United States, 32806

Jacksonville, Florida, United States, 32216

Bradenton, Florida, United States, 34208
United States, Illinois

Libertyville, Illinois, United States, 60048
United States, Kansas

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

Troy, Michigan, United States, 48085
United States, Nebraska

Omaha, Nebraska, United States, 68105
United States, Nevada

Las Vegas, Nevada, United States, 89128
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73103
United States, Oregon

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

Memphis, Tennessee, United States, 38119
United States, Washington

Bellevue, Washington, United States, 98004

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Laura Gault, MD, PhD

Abbott

More Information

Responsible Party:	Abbott ( Laura Gault, MD, PhD )
Study ID Numbers:	M10-345
Study First Received:	March 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00640419
Health Authority:	United States: Food and Drug Administration

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 14, 2009