Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD

Exclusion Criteria

• •1. Blood pressure outside the 95th percentile for age and gender
• •2. Pulse of \<50 (age 6 - 17), or \>120 (age 6 - 12), or \>125 (age 13 - 17)
• •3. Known non-responder to amphetamine treatment
• •4. Documented allergy, intolerance, or hypersensitivity to amphetamine
• •5. Currently taking an ADHD medication that is providing symptom control with no residual impairment at home or school and has acceptable tolerability and adherence
• •6. Recent history (within the past 6 months) of suspected substance abuse or dependence disorder (including nicotine)
• •7. History of seizures during the last 2 years (excluding infantile febrile seizures), a tic disorder (exclusive of transient tic disorder), a current diagnosis, and/or a family history of Tourette's Disorder. Mild medication-induced tics were not exclusionary
• •8. Any psychiatric disorder that could interfere with study participation or the safety of the subject or other participants, such as conduct disorder (CD) or oppositional defiant disorder (ODD) with a history of prominent aggressive outbursts. Children meeting CD or ODD but without prominent aggression will be allowed to enroll at the discretion of the Investigator
• •9. Autism or Asperger's Disorder
• •10. Family history (first degree relatives) of sudden cardiac death
• •11. Current controlled (requiring medication) or uncontrolled comorbid psychiatric conditions such as post-traumatic stress disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, was considered a suicide risk, had recent (last 6 months) suicidal ideation, or any lifetime self-harm event
• •12. History of abnormal thyroid function
• •13. Has a body mass index (BMI) for age greater than 95th percentile per Centers for Disease Control BMI (for gender-specific charts)
• •14. Known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug
• •15. Any skin abnormality present at the potential application site (i.e., infection, rash, atrophy, excessive fragility or dryness, any cut or abrasion, or tattoo)
• •16. History of hypersensitivity, allergy to topical medication, preparation, or adhesive dressings
• •17. Concurrent chronic or significant acute illnesses (such as severe allergic rhinitis or an infectious process requiring antibiotics, unless expected to resolve or has resolved by Day 0) disability or any unstable medical condition that in the Investigator's opinion would lead to difficulty complying with the protocol requirements
• •18. Used any investigational drug within 30 days of the Screening visit
• •19. History of physical, sexual, or emotional abuse in the last year
• •20. Medical history of hepatitis A/B/C or HIV
• •21. Positive urine drug screen for drugs of abuse