Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17

A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

Inclusion Criteria:

• Subjects with a primary diagnosis of ADHD
• Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

• Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
• Subject weighs less than 55 lbs or is morbidly overweight with a BMI => 35
• Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
• Subject is pregnant or lactating