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

Attention-Deficit/Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528697
• Other study ID #: M06-888
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2007
• Last updated: January 21, 2013
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

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.
• atomoxetine
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
• placebo
Subject will take a tablet once daily for 8 weeks

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 6000	Austin	Texas
United States	Site Reference ID/Investigator# 5978	Bellevue	Washington
United States	Site Reference ID/Investigator# 5986	Boulder	Colorado
United States	Site Reference ID/Investigator# 5993	Bradenton	Florida
United States	Site Reference ID/Investigator# 5994	Charleston	South Carolina
United States	Site Reference ID/Investigator# 5987	Clementon	New Jersey
United States	Site Reference ID/Investigator# 5979	El Centro	California
United States	Site Reference ID/Investigator# 5996	Eugene	Oregon
United States	Site Reference ID/Investigator# 5998	Herndon	Virginia
United States	Site Reference ID/Investigator# 5995	Jacksonville	Florida
United States	Site Reference ID/Investigator# 5997	Las Vegas	Nevada
United States	Site Reference ID/Investigator# 5999	Little Rock	Arkansas
United States	Site Reference ID/Investigator# 5976	Memphis	Tennessee
United States	Site Reference ID/Investigator# 5983	Middleton	Wisconsin
United States	Site Reference ID/Investigator# 5981	Northbrook	Illinois
United States	Site Reference ID/Investigator# 5992	Omaha	Nebraska
United States	Site Reference ID/Investigator# 5977	Orlando	Florida
United States	Site Reference ID/Investigator# 5982	Overland Park	Kansas
United States	Site Reference ID/Investigator# 5984	Portland	Oregon
United States	Site Reference ID/Investigator# 5980	Salem	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-RS-IV (HV) - Administered by study doctor		Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56	No
Secondary	Health Outcomes Measurements		Baseline to Final Evaluation of 8-week treatment period	No
Secondary	Clinical Global Impression-ADHD-Severity Scale		Baseline to Final Evaluation of 8-week treatment period	No
Secondary	Parent Rating Scales		Baseline to Final Evaluation of 8-week treatment period	No
Secondary	Teacher Rating Scale		Baseline to Final Evaluation of 8-week treatment period	No