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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00443391
First received: March 2, 2007
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: ABT-089
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Long-Term Safety and Tolerability of ABT-089 in Adults 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 AbbVie:

Primary Outcome Measures:
  • CAARS:INV [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AAQoL [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • WPAI [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • RUQ [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • FTND [ Time Frame: Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]

Enrollment: 141
Study Start Date: February 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ABT-089
Open label study, subjects will take up to 80mg daily for 24 months.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject was randomized into Study M06-855 and completed treatment in Periods 1 and 2 and the 2-week Extension Period
  • If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study
  • If female, the result of a pregnancy tests are negative
  • The subject is judged to be in generally good health

Exclusion Criteria:

  • More than 7 days have elapsed since the last dose of study drug in Study M06-855
  • The subject has taken any ADHD medication between the last dose of study drug in Study M06-855 and the first dose of study drug in the current study
  • The subject anticipates a move outside the geographic area
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443391

  Show 21 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Laura Gault, MD, PhD, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00443391     History of Changes
Other Study ID Numbers: M06-889
Study First Received: March 2, 2007
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
ADHD

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