A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
Attention-Deficit/Hyperactivity Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-089
atomoxetine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention-Deficit/Hyperactivity Disorder
Eligibility Criteria
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
Sites / Locations
- Site Reference ID/Investigator# 5999
- Site Reference ID/Investigator# 5979
- Site Reference ID/Investigator# 5986
- Site Reference ID/Investigator# 5993
- Site Reference ID/Investigator# 5995
- Site Reference ID/Investigator# 5977
- Site Reference ID/Investigator# 5981
- Site Reference ID/Investigator# 5982
- Site Reference ID/Investigator# 5992
- Site Reference ID/Investigator# 5997
- Site Reference ID/Investigator# 5987
- Site Reference ID/Investigator# 5996
- Site Reference ID/Investigator# 5984
- Site Reference ID/Investigator# 5980
- Site Reference ID/Investigator# 5994
- Site Reference ID/Investigator# 5976
- Site Reference ID/Investigator# 6000
- Site Reference ID/Investigator# 5998
- Site Reference ID/Investigator# 5978
- Site Reference ID/Investigator# 5983
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
5
6
Arm Description
Lowest ABT-089 dose
Low-medium ABT-089 dose
Medium-high ABT-089 dose
Highest ABT-089 dose
atomoxetine
placebo
Outcomes
Primary Outcome Measures
ADHD-RS-IV (HV) - Administered by study doctor
Secondary Outcome Measures
Health Outcomes Measurements
Clinical Global Impression-ADHD-Severity Scale
Parent Rating Scales
Teacher Rating Scale
Full Information
NCT ID
NCT00528697
First Posted
September 11, 2007
Last Updated
January 21, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT00528697
Brief Title
A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Lowest ABT-089 dose
Arm Title
2
Arm Type
Experimental
Arm Description
Low-medium ABT-089 dose
Arm Title
3
Arm Type
Experimental
Arm Description
Medium-high ABT-089 dose
Arm Title
4
Arm Type
Experimental
Arm Description
Highest ABT-089 dose
Arm Title
5
Arm Type
Active Comparator
Arm Description
atomoxetine
Arm Title
6
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
ABT-089
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Intervention Description
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subject will take a tablet once daily for 8 weeks
Primary Outcome Measure Information:
Title
ADHD-RS-IV (HV) - Administered by study doctor
Time Frame
Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Secondary Outcome Measure Information:
Title
Health Outcomes Measurements
Time Frame
Baseline to Final Evaluation of 8-week treatment period
Title
Clinical Global Impression-ADHD-Severity Scale
Time Frame
Baseline to Final Evaluation of 8-week treatment period
Title
Parent Rating Scales
Time Frame
Baseline to Final Evaluation of 8-week treatment period
Title
Teacher Rating Scale
Time Frame
Baseline to Final Evaluation of 8-week treatment period
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Gault, MD, PhD, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 5999
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site Reference ID/Investigator# 5979
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Site Reference ID/Investigator# 5986
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Site Reference ID/Investigator# 5993
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Site Reference ID/Investigator# 5995
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Site Reference ID/Investigator# 5977
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 5981
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
Site Reference ID/Investigator# 5982
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Site Reference ID/Investigator# 5992
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Site Reference ID/Investigator# 5997
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Site Reference ID/Investigator# 5987
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Site Reference ID/Investigator# 5996
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site Reference ID/Investigator# 5984
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Reference ID/Investigator# 5980
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Site Reference ID/Investigator# 5994
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Site Reference ID/Investigator# 5976
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Site Reference ID/Investigator# 6000
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Site Reference ID/Investigator# 5998
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Site Reference ID/Investigator# 5978
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Site Reference ID/Investigator# 5983
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21156272
Citation
Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25.
Results Reference
derived
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A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
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