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

January 10, 2013 updated by: AbbVie (prior sponsor, Abbott)

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lafayette, California, United States, 94549
        • Site Reference ID/Investigator# 7546
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Site Reference ID/Investigator# 7551
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 7553
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 7545
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Site Reference ID/Investigator# 7552
      • Troy, Michigan, United States, 48085
        • Site Reference ID/Investigator# 7548
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site Reference ID/Investigator# 7554
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 7547
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Site Reference ID/Investigator# 7555
    • Virginia
      • Virginia Beach, Virginia, United States, 23452
        • Site Reference ID/Investigator# 7549
    • Washington
      • Bellevue, Washington, United States, 98007
        • Site Reference ID/Investigator# 7550
      • Seattle, Washington, United States, 98104
        • Site Reference ID/Investigator# 7631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CAARS: Inv Total Score
Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56
TASS, AAQoL, WPAI
Time Frame: Day -1, Day 28, Day 56
Day -1, Day 28, Day 56
BRIEF-A, FTND
Time Frame: Day-1, Day 56
Day-1, Day 56
QSU-Brief, Number of Cigarettes smoked per day
Time Frame: Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Earle Bain, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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