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

Primary Purpose

Attention-Deficit/Hyperactivity Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-089
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Ref #/Investigator 6800
  • Site Ref #/Investigator 6812
  • Site Ref #/Investigator 8366
  • Site Ref #/Investigator 6808
  • Site Ref #/Investigator 6827
  • Site Ref #/Investigator 8383
  • Site Ref #/Investigator 6802
  • Site Ref #/Investigator 6824
  • Site Ref #/Investigator 8428
  • Site Ref #/Investigator 6902
  • Site Ref #/Investigator 6856
  • Site Ref #/Investigator 6683
  • Site Ref #/Investigator 8297
  • Site Ref #/Investigator 6682
  • Site Ref #/Investigator 6811
  • Site Ref #/Investigator 8701
  • Site Ref #/Investigator 6681
  • Site Ref #/Investigator 6799
  • Site Ref #/Investigator 7955
  • Site Ref #/Investigator 6836
  • Site Ref #/Investigator 6835
  • Site Ref #/Investigator 6791
  • Site Ref #/Investigator 6838

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

ADHD-RS-IV (HV)
CGI-ADHD-S

Secondary Outcome Measures

Full Information

First Posted
November 5, 2007
Last Updated
August 18, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00554385
Brief Title
A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
The Long-term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADHD-RS-IV (HV)
Time Frame
Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12
Title
CGI-ADHD-S
Time Frame
Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Gault, M.D., Ph.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref #/Investigator 6800
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site Ref #/Investigator 6812
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Site Ref #/Investigator 8366
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Site Ref #/Investigator 6808
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Ref #/Investigator 6827
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Ref #/Investigator 8383
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Site Ref #/Investigator 6802
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Site Ref #/Investigator 6824
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Site Ref #/Investigator 8428
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Site Ref #/Investigator 6902
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Site Ref #/Investigator 6856
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Site Ref #/Investigator 6683
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Site Ref #/Investigator 8297
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site Ref #/Investigator 6682
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site Ref #/Investigator 6811
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Ref #/Investigator 8701
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Ref #/Investigator 6681
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Site Ref #/Investigator 6799
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Site Ref #/Investigator 7955
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Site Ref #/Investigator 6836
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Site Ref #/Investigator 6835
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Site Ref #/Investigator 6791
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Site Ref #/Investigator 6838
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

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

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