Safety and Tolerability 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 (ADHD).

Key facts

Study ID

NCT00640419

Run by

AbbVie (prior sponsor, Abbott)

People needed

121

Starts

2008-03-01

Expected to finish

2008-07-01

Last updated by the study team

2013-01-18

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).
• 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.

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 7536 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 7954 — Bradenton, Florida, United States
• Site Reference ID/Investigator# 7543 — Jacksonville, Florida, United States
• Site Reference ID/Investigator# 7542 — Orlando, Florida, United States
• Site Reference ID/Investigator# 7537 — Libertyville, Illinois, United States
• Site Reference ID/Investigator# 7561 — Overland Park, Kansas, United States
• Site Reference ID/Investigator# 7560 — Troy, Michigan, United States
• Site Reference ID/Investigator# 7559 — Omaha, Nebraska, United States
• Site Reference ID/Investigator# 7541 — Las Vegas, Nevada, United States
• Site Reference ID/Investigator# 7564 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 7538 — Portland, Oregon, United States
• Site Reference ID/Investigator# 7540 — Memphis, Tennessee, United States
• Site Reference ID/Investigator# 7544 — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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