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

A Phase II Study to Assess the Safety, Tolerability and Efficacy of SPD503 Administered to Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

Inclusion Criteria:

• Subjects with a primary diagnosis of ADHD
• Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4
• Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
• Subject weighs > 55 lbs and is not morbidly overweight

Exclusion Criteria:

• Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
• Subject has a history of seizure disorder
• Subject has any specific cardiac condition or family history of significant cardiac condition
• Subject is pregnant, lactating or within six month post-partum