Clinical trial NCT00640419: Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety and Efficacy of 0.7 mg/kg/Day and 1.4 mg/kg/Day of ABT-089 in the Treatment of 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: 2008-03-21
Enrollment: 121
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 (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).
* Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
* Subject weights at least 37 pounds (17 kg)
* Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Subject can swallow pills and subjects and parents are able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria:

* Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger syndrome, pervasive developmental disorder, tics, Tourette syndrome, mental retardation, seizure disorder or traumatic brain injury.
* Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind.
* Subject has a history of, or ongoing, serious medical problem.
* Subject has a history of significant allergic reaction to any drug.
* Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
* Subject requires ongoing treatment with any psychiatric medication.

Primary outcomes:
measure: ADHD-RS-IV (HV)
timeFrame: Screening, Day -1, Day 7, Day 14, Day 28, Day 42
Secondary outcomes:
measure: CSHQ
timeFrame: Day-1, Day 28, Day 42
measure: CGI-P
timeFrame: Day -1, Day 21, Day 42
measure: BRIEF
timeFrame: Day -1, Day 28, Day 42
measure: CGI-ADHD-S
timeFrame: Screening, Day -1, Day 7, Day 14, Day 28 and Day 42
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 7536
state: Arkansas
city: Bradenton
country: United States
facility: Site Reference ID/Investigator# 7954
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 7543
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 7542
state: Florida
city: Libertyville
country: United States
facility: Site Reference ID/Investigator# 7537
state: Illinois
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 7561
state: Kansas
city: Troy
country: United States
facility: Site Reference ID/Investigator# 7560
state: Michigan
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 7559
state: Nebraska
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 7541
state: Nevada
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 7564
state: Oklahoma
city: Portland
country: United States
facility: Site Reference ID/Investigator# 7538
state: Oregon
city: Memphis
country: United States
facility: Site Reference ID/Investigator# 7540
state: Tennessee
city: Bellevue
country: United States
facility: Site Reference ID/Investigator# 7544
state: Washington
Study officials:
affiliation: AbbVie
name: Laura Gault
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.