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

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ClinicalTrials.gov Identifier: NCT00554385
Recruitment Status : Terminated
First Posted : November 6, 2007
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

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

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Drug: ABT-089 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Long-term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study
Study Start Date : November 2007
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 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.



Primary Outcome Measures :
  1. ADHD-RS-IV (HV) [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ]
  2. CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 ]


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554385


  Show 23 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Gault, M.D., Ph.D. Abbott

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00554385     History of Changes
Other Study ID Numbers: M10-178
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms