Long Term 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:
NCT00686933
First received: May 28, 2008
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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 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 for Subjects Completing Study M10-346

Resource links provided by NLM:


Further study details as provided by AbbVie:

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

Secondary Outcome Measures:
  • CAARS:Self [ Time Frame: Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • BRIEF-A [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • AAQOL [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • WPAI [ Time Frame: Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
  • FTND [ Time Frame: Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: May 2008
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
Subjects will take up to 80 mg 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00686933     History of Changes
Other Study ID Numbers: M10-425
Study First Received: May 28, 2008
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Attention-Deficit/Hyperactivity Disorder

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

ClinicalTrials.gov processed this record on October 29, 2014