PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD

Exclusion Criteria

• •1. Has blood pressure and pulse greater than the 95th percentile for age and gender
• •2. Has current or recent history (within the past 6 months) of drug abuse or dependence disorder in the subject or the immediate family or by someone living at the participant's' home or positive urine drug screen for stimulant medication (other than currently prescribed stimulant for the treatment of ADHD) or drugs of abuse at the screening visit
• •3. Has untreated thyroid disease, glaucoma, Gilles de la Tourette's disorder, chronic tics or a history of seizures during the last 2 years (except simple febrile seizures), a tic disorder (exclusive of transient tic disorder). Mild medication-induced tics are not exclusionary
• •4. Primary and/or comorbid psychiatric diagnosis other than ADHD with the exception of simple phobias, motor skill disorders, communication disorders, learning disorders and adjustment disorders so long as such disorder is judged not to interfere with study participation or the safety of the subject or other participants. Children meeting conduct disorder or oppositional defiant disorder criteria but without history of prominent aggressive outbursts that could interfere with study participation or the safety of the subject or other participants will be allowed to enroll at the discretion of the investigator
• •5. Subjects with a family history (first degree relatives) of sudden cardiac death require review and approval by the medical monitor for participation in the study
• •6. Has a current or recent history of hypertension, 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
• •7. Has a concurrent medical condition that, in the opinion of the investigator, could cause participation in this study to be detrimental to the subject
• •8. Has used any investigational drug within 30 days of the screening visit
• •9. Has a known history of physical, sexual, or emotional abuse in the last year
• •10. Has a medical history of hepatitis A, B, C or human immunodeficiency virus, or tests positive for any of these at screening
• •11. Has a positive urine pregnancy test (if applicable) at screening
• •12. Has positive findings on C-SSRS for suicidal ideation or behaviors at screening.