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

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of 0.7 mg/kg/Day and 1.4 mg/kg/Day of ABT-089 in the Treatment of Children With Attention Deficit-Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

Further study details as provided by AbbVie:

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 ]

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 ]
CGI-ADHD-S [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28 and 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
Experimental: 1	Drug: ABT-089 Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
Experimental: 2	Drug: ABT-089 Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
Placebo Comparator: 3	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
Site Reference ID/Investigator# 7536
Little Rock, Arkansas, United States, 72205
United States, Florida
Site Reference ID/Investigator# 7954
Bradenton, Florida, United States, 34208
Site Reference ID/Investigator# 7543
Jacksonville, Florida, United States, 32216
Site Reference ID/Investigator# 7542
Orlando, Florida, United States, 32806
United States, Illinois
Site Reference ID/Investigator# 7537
Libertyville, Illinois, United States, 60048
United States, Kansas
Site Reference ID/Investigator# 7561
Overland Park, Kansas, United States, 66212
United States, Michigan
Site Reference ID/Investigator# 7560
Troy, Michigan, United States, 48085
United States, Nebraska
Site Reference ID/Investigator# 7559
Omaha, Nebraska, United States, 68198
United States, Nevada
Site Reference ID/Investigator# 7541
Las Vegas, Nevada, United States, 89128
United States, Oklahoma
Site Reference ID/Investigator# 7564
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Site Reference ID/Investigator# 7538
Portland, Oregon, United States, 97210
United States, Tennessee
Site Reference ID/Investigator# 7540
Memphis, Tennessee, United States, 38119
United States, Washington
Site Reference ID/Investigator# 7544
Bellevue, Washington, United States, 98007

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Laura Gault

AbbVie

More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. Epub 2010 Nov 25.

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT00640419 History of Changes
Other Study ID Numbers:	M10-345
Study First Received:	March 18, 2008
Last Updated:	January 10, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013