Text Size

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00554385
First received: November 5, 2007
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 283
Study Start Date: November 2007
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: ABT-089

  Eligibility

Ages Eligible for Study:   6 Years to 12 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: Laura Gault, M.D., Ph.D. Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00554385     History of Changes
Other Study ID Numbers: M10-178
Study First Received: November 5, 2007
Last Updated: August 18, 2011
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 23, 2013