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

Inclusion Criteria:

1. Males or females greater than or equal to 6 and less than or equal to 12 years of age

2. Females who are non-pregnant and non-nursing

3. Females of child-bearing potential who agree to practice a clinically accepted method
of contraception during the study and for at least one month prior to study dosing and
one month following completion of the study. Acceptable contraceptive methods include
abstinence, oral contraception, surgical sterilization (bilateral tubal ligation,
bilateral oophorectomy or hysterectomy), intrauterine device, or diaphragm in addition
to spermicidal foam and condom on male partner, or systemic contraception (e.g.
levonorgestrel-releasing implant)

4. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or
predominately inattentive type) by a psychiatrist, psychologist, developmental
pediatrician or licensed allied healthcare professional using the DSM-5 and confirmed
by administration of a structured diagnostic interview using the K-SADS-PL

5. Ratings on the ADHD-RS-5 based on when the subject is not receiving treatment for
ADHD, the subject must have ≥ 90th percentile normative value for gender and age in at
least 1 of the categories: total score, inattentive subscale or hyperactive/impulse
subscale

6. Unsatisfied with his or her current pharmacological therapy for treatment of ADHD or
not currently receiving pharmacological therapy for ADHD. Inclusion of subjects who
are naïve to pharmacological therapy for ADHD is permitted

7. Must be functioning at an age-appropriate level intellectually as determined by an
intelligence quotient of ≥ 80 on a documented IQ assessment such as the WASI-II
vocabulary and matrix reasoning components, or the KBIT-2

8. Must have the ability to complete the PERMP assessments

9. Have parental consent (signed informed consent form) and written or verbal assent from
the subject

10. Subject and parent(s)/caregiver are willing and able to comply with all the protocol
requirements and parent(s) or caregiver must be able to provide transportation for the
subject to and from the analog classroom sessions

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.