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

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention-Deficit/Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT00528697

Run by

AbbVie (prior sponsor, Abbott)

People needed

278

Starts

2007-09-01

Expected to finish

2008-04-01

Last updated by the study team

2013-01-29

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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