| Eligibility |
Inclusion Criteria:
1. New Subjects must be at least 4 years old and less than 5 years and 10 months old at
Screening.
2. Subjects must have a body weight within the 5th and 95th percentile according to the
gender-specific weight-for-age percentile charts from the Centers for Disease Control
and Prevention (CDC).
3. Subject must be in general good health defined as the absence of any clinically
relevant abnormalities as determined by the Investigator based on physical
examinations, vital signs, ECGs, medical history, and clinical laboratory values
(chemistry, hematology and urinalysis) at Screening.
4. At least one parent/legal guardian of the subject must voluntarily give written
permission for the subject to participate in the study.
5. Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth
Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or
hyperactive/impulsive presentation) per clinical evaluation and confirmed by the
Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
6. Subject must have had ADHD symptoms present for at least 6 months prior to the
Screening Visit.
7. Subject must be able and willing to wash out current stimulant ADHD medications,
including herbal medications from 5 days prior to the start of the Dose Optimization
Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or
Early Termination (ET); and wash out non-stimulant ADHD medications from 14 days prior
to the start of the Dose Optimization Phase, and abstain from taking these to the end
of the Treatment Phase (Visit 17) or ET.
8. Subject must have a score of =4 (Moderately Ill) on the clinician-administered
Clinical Global Impressions-Severity (CGI-S) scale.
9. Subject functions at an age-appropriate level intellectually, as determined by the
Investigator.
10. Subject must have age and sex adjusted ratings of =90th percentile Total Score on the
ADHD-RS-IV (Preschool Version) rated over the past 6 months.
11. Subject must have a systolic and diastolic blood pressure below the 95th percentile
for age, and gender according to the 2017 AAP guidelines (Flynn 2017) based on the
average of 3 measurements 2-5 minutes apart.
12. Subject's parent/legal guardian and caregiver (if applicable) must understand and be
willing and able to comply with all study procedures and visit schedule.
13. Subject's parent/legal guardian, and caregiver (if applicable) must be able to speak
and understand English or Spanish and be able to communicate satisfactorily with the
Investigator and study coordinator.
Exclusion Criteria
1. Subject with any clinically significant chronic medical condition that, in the
judgment of the Investigator, may interfere with the participant's ability to
participate in the study.
2. Subject has any diagnosis of bipolar I or II disorder, major depressive disorder,
conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism
spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual
disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or
behavioral disturbances.
3. Subject has generalized anxiety disorder or panic disorder that has been the primary
focus of treatment at any time during the 12 months prior to Screening, or that has
required pharmacotherapy any time during the 6 months prior to Screening.
4. Subject has evidence of any chronic disease of the central nervous system (CNS) such
as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related
disorders that might occur in childhood (e.g., Duchenne Muscular dystrophy, myasthenia
gravis, or other neurologic or serious neuromuscular disorders), or history of
persistent neurological symptoms attributable to serious head injury.
5. Subject taking anticonvulsants for seizure control currently or within the past 2
years before Screening are not eligible for study participation.
6. Subject has a current (last month) psychiatric diagnosis other than specific phobia,
motor skills disorders, ODD, sleep disorders, elimination disorders, adjustment
disorders, learning disorders, or communication disorders.
7. In the opinion of the Investigator, subject has clinically significant suicidal
ideation/behavior, based on history of attempted suicide and the C-SSRS assessment at
Screening.
8. Subject has any clinically significant unstable medical abnormality, chronic disease
(including asthma or diabetes), or a history of a clinically significant abnormality
of the cardiovascular (including cardiomyopathy, serious arrhythmias, structural
cardiac disorders, or severe hypertension), gastrointestinal, respiratory, hepatic, or
renal systems, or a disorder or history of a condition (e.g., malabsorption,
gastrointestinal surgery) that may interfere with drug absorption, distribution,
metabolism, or excretion of study drug.
9. Subject has a history or presence of abnormal ECGs, which in the Investigator's
opinion is clinically significant.
10. Subject has a history of, or currently has a malignancy.
11. Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone
(TSH) =0.8 x the lower limit of normal (LLN) or =1.25 x the upper limit of normal
(ULN) for the reference laboratory at Screening.
12. Subject has greater than trace proteinuria on the urinalysis at Screening.
13. A current or recent (past 12 months) history of drug abuse in someone living in the
subjects' home.
14. Subject has a positive urine screen for drugs of abuse at Screening. If the urine test
is positive for any of the analytes at Screening, the subject will be excluded from
study participation, with the exception of the following: Depending on a subject's
current ADHD medication at Screening, the urine screen may test positive for MPH for
treatment of their ADHD.
15. Subject has participated in any other clinical study with an investigational
drug/product within 30 days or at least 5 half-lives, whichever is longer, prior to
Screening, except for participation in Study KP415.P01.
16. Subject has taken ADHD medications from more than one class within 30 days prior to
Screening. Subjects on a stable dose of one ADHD medication with occasional use of
ADHD medications from another class are eligible at the discretion of the
Investigator.
17. Subject has demonstrated lack of response or intolerability to adequate dose and
duration of treatment with methylphenidate products.
18. Subject is using or planning to use prohibited drugs during the trial as specified in
the protocol.
19. Subject is planning to initiate psychotherapy during the study (subjects participating
in psychotherapy beginning at least 4 weeks before study initiation are permitted to
continue).
20. Subject has a history of severe allergies or adverse drug reactions to more than one
class of medications.
21. Subject has a history of allergic reaction or a known or suspected sensitivity to
methylphenidate or any substance that is contained in the study drug.
22. Subject, parent/legal guardian and caregiver (if applicable at the Investigator's
discretion) has commitments during the study that would interfere with attending study
visits.
23. Subject or subject's family anticipates a move outside the geographic range of the
investigative site during the study or plans extended travel inconsistent with the
recommended visit interval during study duration.
24. Subject has one or more siblings living in the same household who are enrolled in this
or another clinical drug trial.
25. Subject shows evidence of current physical, sexual, or emotional abuse.
26. Subject is, in the opinion of the Investigator, unsuitable in any other way to
participate in this study.
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