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Trial record 2 of 11 for:    ABT-089

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

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ClinicalTrials.gov Identifier: NCT00686933
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 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 for Subjects Completing Study M10-346
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: ABT-089
Subjects will take up to 80 mg daily for 24 months




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

Secondary Outcome Measures :
  1. CAARS:Self [ Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ]
  2. BRIEF-A [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ]
  3. AAQOL [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ]
  4. WPAI [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ]
  5. FTND [ Time Frame: Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ]


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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 M10-346 and completed the study.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
  • Male subjects must agree to comply with applicable contraceptive requirements.
  • The subject is judged to be in generally good health.

Exclusion Criteria:

  • The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study.
  • 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): NCT00686933


Locations
United States, California
Site Reference ID/Investigator# 8315
Lafayette, California, United States, 94549
United States, Florida
Site Reference ID/Investigator# 8306
Jacksonville, Florida, United States, 32216
Site Reference ID/Investigator# 8308
Orlando, Florida, United States, 32806
United States, Kansas
Site Reference ID/Investigator# 8314
Overland Park, Kansas, United States, 66212
United States, Michigan
Site Reference ID/Investigator# 8307
Farmington Hills, Michigan, United States, 48336
Site Reference ID/Investigator# 8318
Troy, Michigan, United States, 48085
United States, Oregon
Site Reference ID/Investigator# 8309
Eugene, Oregon, United States, 97401
Site Reference ID/Investigator# 8316
Portland, Oregon, United States, 97210
United States, Tennessee
Site Reference ID/Investigator# 8310
Memphis, Tennessee, United States, 38119
United States, Virginia
Site Reference ID/Investigator# 8319
Virginia Beach, Virginia, United States, 23452
United States, Washington
Site Reference ID/Investigator# 8305
Bellevue, Washington, United States, 98007
Site Reference ID/Investigator# 8320
Seattle, Washington, United States, 98104
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Earle Bain, MD AbbVie

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00686933     History of Changes
Other Study ID Numbers: M10-425
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Attention-Deficit/Hyperactivity Disorder

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