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

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of 0.7 mg/kg/Day and 1.4 mg/kg/Day of ABT-089 in the Treatment of 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 (ADHD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

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# 7536
    • Florida
      • Bradenton, Florida, United States, 34208
        • Site Reference ID/Investigator# 7954
      • Jacksonville, Florida, United States, 32216
        • Site Reference ID/Investigator# 7543
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 7542
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Site Reference ID/Investigator# 7537
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 7561
    • Michigan
      • Troy, Michigan, United States, 48085
        • Site Reference ID/Investigator# 7560
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Site Reference ID/Investigator# 7559
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Site Reference ID/Investigator# 7541
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Site Reference ID/Investigator# 7564
    • Oregon
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 7538
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Site Reference ID/Investigator# 7540
    • Washington
      • Bellevue, Washington, United States, 98007
        • Site Reference ID/Investigator# 7544

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).
  • Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
  • Subject weights at least 37 pounds (17 kg)
  • 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.
  • Subject can swallow pills and subjects and parents are 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 bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
  • Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ABT-089
Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
Experimental: 2
Drug: ABT-089
Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.
Placebo Comparator: 3
Drug: placebo
Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
CSHQ
Time Frame: Day-1, Day 28, Day 42
Day-1, Day 28, Day 42
CGI-P
Time Frame: Day -1, Day 21, Day 42
Day -1, Day 21, Day 42
BRIEF
Time Frame: Day -1, Day 28, Day 42
Day -1, Day 28, Day 42
CGI-ADHD-S
Time Frame: Screening, Day -1, Day 7, Day 14, Day 28 and Day 42
Screening, Day -1, Day 7, Day 14, Day 28 and Day 42

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, 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)

July 1, 2008

Study Completion (Actual)

July 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

  • M10-345

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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