Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder

This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.

Inclusion Criteria:

• primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria
• functioning at age appropriate levels intellectually
• blood pressure measurements within the 95th percentile for their gender, height and age
• ECG results are within the normal range

Exclusion Criteria:

• comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations
• history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder
• weighs less than 55 lbs (25 kg)or is significantly overweight or obese
• clinically significant ECG abnormality
• documented allergy or intolerance to amphetamines