Safety, Tolerability and Efficacy 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:
NCT00640185
First received: March 18, 2008
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • CAARS: Inv Total Score [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self [ Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 ] [ Designated as safety issue: No ]
  • TASS, AAQoL, WPAI [ Time Frame: Day -1, Day 28, Day 56 ] [ Designated as safety issue: No ]
  • BRIEF-A, FTND [ Time Frame: Day-1, Day 56 ] [ Designated as safety issue: No ]
  • QSU-Brief, Number of Cigarettes smoked per day [ Time Frame: Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Drug: Placebo
Subjects will take one or two placebos once daily for the duration of the study.
Experimental: 2 Drug: ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Drug: Placebo
Subjects will take one or two placebos once daily for the duration of the study.
Experimental: 3 Drug: ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Drug: Placebo
Subjects will take one or two placebos once daily for the duration of the study.

  Eligibility

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

Inclusion Criteria:

  • Have voluntarily signed an informed consent form.
  • Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.
  • Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
  • Female subjects of child-bearing 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.
  • Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria:

  • Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
  • Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
  • Subject has a history of, or ongoing, serious medical problem.
  • Subject has a history of significant allergic reaction to any drug.
  • Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
  • Subject requires ongoing treatment with any psychiatric medication.
  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: NCT00640185

Locations
United States, California
Site Reference ID/Investigator# 7546
Lafayette, California, United States, 94549
United States, Florida
Site Reference ID/Investigator# 7551
Jacksonville, Florida, United States, 32216
Site Reference ID/Investigator# 7553
Orlando, Florida, United States, 32806
United States, Kansas
Site Reference ID/Investigator# 7545
Overland Park, Kansas, United States, 66212
United States, Michigan
Site Reference ID/Investigator# 7552
Farmington Hills, Michigan, United States, 48336
Site Reference ID/Investigator# 7548
Troy, Michigan, United States, 48085
United States, Oregon
Site Reference ID/Investigator# 7554
Eugene, Oregon, United States, 97401
Site Reference ID/Investigator# 7547
Portland, Oregon, United States, 97210
United States, Tennessee
Site Reference ID/Investigator# 7555
Memphis, Tennessee, United States, 38119
United States, Virginia
Site Reference ID/Investigator# 7549
Virginia Beach, Virginia, United States, 23452
United States, Washington
Site Reference ID/Investigator# 7550
Bellevue, Washington, United States, 98007
Site Reference ID/Investigator# 7631
Seattle, Washington, United States, 98104
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Earle Bain AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00640185     History of Changes
Other Study ID Numbers: M10-346
Study First Received: March 18, 2008
Last Updated: January 10, 2013
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 August 20, 2014