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

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

This study is enrolling participants by invitation only.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00554385

Purpose

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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	The Long-Term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study

Further study details as provided by Abbott:

Primary Outcome Measures:

ADHD-RS-IV (HV) [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]
CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	270
Study Start Date:	November 2007
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-089 Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.

Eligibility

Ages Eligible for Study:	6 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
If female, subject must be practicing at least one method of birth control throughout the study.
If female, the result of a pregnancy test is negative.
The subject is judged to be in generally good health.

Exclusion Criteria:

The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
The subject has a positive urine drug screen for alcohol or drugs of abuse.
The subject anticipates a move outside the geographic area.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554385

Show 23 Study Locations

Sponsors and Collaborators

Abbott

Investigators


Study Director:	George Apostol, M.D.	Abbott

More Information

Responsible Party:	Abbott ( George Apostol, M.D. Study Director )
Study ID Numbers:	M10-178
First Received:	November 5, 2007
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00554385
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 August 29, 2008