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

August 18, 2011 updated by: Abbott

The Long-term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study

The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

283

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 Ref #/Investigator 6800
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Site Ref #/Investigator 6812
    • Florida
      • Bradenton, Florida, United States, 34208
        • Site Ref #/Investigator 8366
      • Jacksonville, Florida, United States, 32216
        • Site Ref #/Investigator 6808
      • Orlando, Florida, United States, 32806
        • Site Ref #/Investigator 6827
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Site Ref #/Investigator 8383
      • Northbrook, Illinois, United States, 60062
        • Site Ref #/Investigator 6802
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Ref #/Investigator 6824
    • Michigan
      • Troy, Michigan, United States, 48085
        • Site Ref #/Investigator 8428
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Site Ref #/Investigator 6902
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Site Ref #/Investigator 6856
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • Site Ref #/Investigator 6683
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Site Ref #/Investigator 8297
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Site Ref #/Investigator 6682
      • Portland, Oregon, United States, 97210
        • Site Ref #/Investigator 6811
      • Portland, Oregon, United States, 97210
        • Site Ref #/Investigator 8701
      • Salem, Oregon, United States, 97301
        • Site Ref #/Investigator 6681
    • South Carolina
      • Charleston, South Carolina, United States, 29405
        • Site Ref #/Investigator 6799
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Site Ref #/Investigator 7955
    • Texas
      • Austin, Texas, United States, 78756
        • Site Ref #/Investigator 6836
    • Virginia
      • Herndon, Virginia, United States, 20170
        • Site Ref #/Investigator 6835
    • Washington
      • Bellevue, Washington, United States, 98007
        • Site Ref #/Investigator 6791
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Site Ref #/Investigator 6838

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:

  • The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
  • If female, subject must be practicing at least one method of birth control throughout the study.
  • If female, the result of a pregnancy test is negative.
  • The subject is judged to be in generally good health.

Exclusion Criteria:

  • The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
  • The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
  • The subject has a positive urine drug screen for alcohol or drugs of abuse.
  • The subject anticipates a move outside the geographic area.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ABT-089
Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADHD-RS-IV (HV)
Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
CGI-ADHD-S
Time Frame: Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12

Collaborators and Investigators

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

Sponsor

Abbott

Investigators

  • Study Director: Laura Gault, M.D., Ph.D., Abbott

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

November 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-178

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.

Clinical Trials on Attention-Deficit/Hyperactivity Disorder

Clinical Trials on ABT-089

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe