Clinical trial NCT00528697: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 278
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ADHD-RS-IV (HV) - Administered by study doctor
timeFrame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56
Secondary outcomes:
measure: Health Outcomes Measurements
timeFrame: Baseline to Final Evaluation of 8-week treatment period
measure: Clinical Global Impression-ADHD-Severity Scale
timeFrame: Baseline to Final Evaluation of 8-week treatment period
measure: Parent Rating Scales
timeFrame: Baseline to Final Evaluation of 8-week treatment period
measure: Teacher Rating Scale
timeFrame: Baseline to Final Evaluation of 8-week treatment period
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 5999
state: Arkansas
city: El Centro
country: United States
facility: Site Reference ID/Investigator# 5979
state: California
city: Boulder
country: United States
facility: Site Reference ID/Investigator# 5986
state: Colorado
city: Bradenton
country: United States
facility: Site Reference ID/Investigator# 5993
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 5995
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 5977
state: Florida
city: Northbrook
country: United States
facility: Site Reference ID/Investigator# 5981
state: Illinois
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 5982
state: Kansas
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 5992
state: Nebraska
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 5997
state: Nevada
city: Clementon
country: United States
facility: Site Reference ID/Investigator# 5987
state: New Jersey
city: Eugene
country: United States
facility: Site Reference ID/Investigator# 5996
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 5984
state: Oregon
city: Salem
country: United States
facility: Site Reference ID/Investigator# 5980
state: Oregon
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 5994
state: South Carolina
city: Memphis
country: United States
facility: Site Reference ID/Investigator# 5976
state: Tennessee
city: Austin
country: United States
facility: Site Reference ID/Investigator# 6000
state: Texas
city: Herndon
country: United States
facility: Site Reference ID/Investigator# 5998
state: Virginia
city: Bellevue
country: United States
facility: Site Reference ID/Investigator# 5978
state: Washington
city: Middleton
country: United States
facility: Site Reference ID/Investigator# 5983
state: Wisconsin
Study officials:
affiliation: AbbVie
name: Laura Gault, MD, PhD, MD
role: STUDY_DIRECTOR
References:
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.