A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

January 21, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-089 in Children 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 children with Attention-Deficit/Hyperactivity Disorder or ADHD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Site Reference ID/Investigator# 5999
    • California
      • El Centro, California, United States, 92243
        • Site Reference ID/Investigator# 5979
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Site Reference ID/Investigator# 5986
    • Florida
      • Bradenton, Florida, United States, 34208
        • Site Reference ID/Investigator# 5993
      • Jacksonville, Florida, United States, 32216
        • Site Reference ID/Investigator# 5995
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 5977
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Site Reference ID/Investigator# 5981
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 5982
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Site Reference ID/Investigator# 5992
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Site Reference ID/Investigator# 5997
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • Site Reference ID/Investigator# 5987
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site Reference ID/Investigator# 5996
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 5984
      • Salem, Oregon, United States, 97301
        • Site Reference ID/Investigator# 5980
    • South Carolina
      • Charleston, South Carolina, United States, 29405
        • Site Reference ID/Investigator# 5994
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Site Reference ID/Investigator# 5976
    • Texas
      • Austin, Texas, United States, 78756
        • Site Reference ID/Investigator# 6000
    • Virginia
      • Herndon, Virginia, United States, 20170
        • Site Reference ID/Investigator# 5998
    • Washington
      • Bellevue, Washington, United States, 98007
        • Site Reference ID/Investigator# 5978
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Site Reference ID/Investigator# 5983

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

6 years to 12 years (Child)

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 parent(s)
  • First grade or higher in a school setting 3 days/week
  • Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG
  • Subject weighs at least 37 pounds (17 kg)
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements
  • Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations

Exclusion Criteria:

  • Subject is not functioning at an age-appropriate level intellectually
  • Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
  • Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind
  • Subject has a history of significant allergic reaction to any drug
  • Subject requires ongoing treatment with any psychiatric medication
  • Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Lowest ABT-089 dose
Drug: ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
Experimental: 2
Low-medium ABT-089 dose
Drug: ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
Experimental: 3
Medium-high ABT-089 dose
Drug: ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
Experimental: 4
Highest ABT-089 dose
Drug: ABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
Active Comparator: 5
atomoxetine
Drug: atomoxetine
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
Placebo Comparator: 6
placebo
Drug: placebo
Subject will take a tablet once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADHD-RS-IV (HV) - Administered by study doctor
Time Frame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Health Outcomes Measurements
Time Frame: Baseline to Final Evaluation of 8-week treatment period
Baseline to Final Evaluation of 8-week treatment period
Clinical Global Impression-ADHD-Severity Scale
Time Frame: Baseline to Final Evaluation of 8-week treatment period
Baseline to Final Evaluation of 8-week treatment period
Parent Rating Scales
Time Frame: Baseline to Final Evaluation of 8-week treatment period
Baseline to Final Evaluation of 8-week treatment period
Teacher Rating Scale
Time Frame: Baseline to Final Evaluation of 8-week treatment period
Baseline to Final Evaluation of 8-week treatment period

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Laura Gault, MD, PhD, MD, 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

September 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 21, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-888

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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