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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  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




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