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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00443391
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 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 Adults With Attention Deficit-Hyperactivity Disorder (ADHD): An Open-Label Extension Study
Study Start Date : February 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: ABT-089
Open label study, subjects will take up to 80mg daily for 24 months.


Outcome Measures

Primary Outcome Measures :
  1. CAARS:INV [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ]
  2. CGI-ADHD-S [ Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ]

Secondary Outcome Measures :
  1. AAQoL [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ]
  2. WPAI [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ]
  3. RUQ [ Time Frame: Day -1, Months 3, 6, 9, 12, 15, 18, 21, 24 ]
  4. FTND [ Time Frame: Day -1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00443391


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

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00443391     History of Changes
Other Study ID Numbers: M06-889
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
ADHD

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