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

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)

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).

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.