PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD
Condition: ADHD
Intervention: PRC-063 oral capsules; Placebo oral capsules
Intervention description: Daily dose; Daily dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase
      3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric
      subjects between 6 to 12 years of age.
    

Eligibility criteria:

        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.