| Eligibility |
Inclusion Criteria:
- Male and female subjects =4 and =12 years of age at the time of informed
consent/assent.
- Females of childbearing potential who are not pregnant and not nursing.
- Females of childbearing potential who agree to practice a clinically accepted method
of contraception during the study and for at least 1 month prior to study dosing and 1
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
(eg, levonorgestrel-releasing implant).
- Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or
predominately inattentive type) by a psychiatrist, psychologist, pediatrician, or
licensed allied healthcare professional using the Diagnostic and Statistical Manual of
Mental Disorders (DSM-5) and confirmed by administration of a structured diagnostic
interview using the Kiddie-Schedule for Affective Disorders and Schizophrenia for
School Age Children-Present and Lifetime DSM-5 version (K-SADS-PL).
- Subjects who have received, or are receiving treatment with medication (amphetamine,
methylphenidate, or non-stimulant) for ADHD must be willing to undergo a washout
period of a minimum of 3 days or 5 half-lives (whichever is longer) prior to study
drug administration. The washout period for prohibited concomitant medications will be
at least 5 half-lives or 3 days, whichever is longer.
- If subjects are currently off treatment, this must be for any reason other than
noncompliance, nonresponse, or intolerance to side effects.
- Ratings on the attention deficit/hyperactivity disorder-Rating Scale, version 5 (ADHD
RS-5) when the subject is not receiving treatment for ADHD must be =90th percentile
normative value for sex and age in at least 1 of the categories: total score,
inattentive subscale, or hyperactive/impulse subscale.
- Dissatisfied with his or her current pharmacological therapy for treatment of ADHD or
not currently receiving pharmacological therapy for ADHD for any reason other than
nonresponse, noncompliance, or tolerability issues with stimulants. Newly diagnosed
and treatment naïve subjects may be included at the discretion of the investigator.
- Must be functioning at an age-appropriate level intellectually as determined by an
intelligence quotient (IQ) of =80 on a documented IQ assessment such as the Wechsler
Abbreviated Scale of Intelligence II (WASI-II) vocabulary and matrix reasoning
components, or the Kaufman Brief Intelligence Test, Second Edition (KBIT-2)
- Parent(s)/legal guardian(s) must have the ability to read and understand the language
in which the informed consent is written and are mentally and physically competent to
provide written informed consent for their child.
- Written or verbal assent from the subject (as applicable).
- Subject and parent(s)/legal guardian/caregiver are willing and able to comply with all
the protocol requirements and parent(s)/legal guardian/caregiver must be able to
provide transportation for the subject to and from the clinic visits.
Exclusion Criteria:
- Has a known allergy, intolerance, or hypersensitivity to methylphenidate.
- History of allergic reactions to tartrazine.
- Known nonresponder to methylphenidate treatment.
- Subject has received a monoamine oxidase inhibitor within 2 weeks before study
treatment.
- Blood pressure and heart rate outside the 95th percentile for age and sex.
- Subject has a current or recent history (within the past 6 months) of drug abuse or
dependence disorder; or someone in the subject's immediate family has a current or
recent history (within the past 6 months) of drug abuse or dependence disorder; or
someone living at the subject's home has a current or recent history (within the past
6 months) of drug abuse or dependence disorder; or subject has a 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.
- Has abnormal thyroid function, glaucoma, Gilles de la Tourette's disorder, a history
of seizures (except simple febrile seizures), or a tic disorder. Mild medication
induced tics are not exclusionary.
- 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.
- 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.
- Subject has a history of disorders of the sensory organs, including deafness,
blindness or the subject is severely or profoundly developmentally disabled.
- Any clinically significant abnormality or clinically significant abnormal laboratory
test results found during screening or a positive test for hepatitis A, hepatitis B,
hepatitis C, or HIV found during screening (subjects who have received a hepatitis A
vaccine and test positive for hepatitis A may be included in the study, at the
discretion of the investigator).
- Use of an investigational drug within 30 days (90 days for biologics) or participation
in an investigational study within 30 days prior to dosing.
- Any reason which, in the opinion of the investigator, would prevent the subject from
participating in the study.
- Clinically significant ECG abnormalities (including but not limited to Wolff
Parkinson-White syndrome, supraventricular tachycardia, left ventricular hypertrophy,
abnormal conduction defect, or other cardiac arrhythmia), or vital sign abnormalities
(normal vital signs should be between 5th and 95th percentile for age) at screening.
- Known history of cardiovascular disorders including hypertension, angina, arterial
occlusive disease, heart failure, hemodynamically significant congenital heart
disease, cardiomyopathies, myocardial infarction, potentially life-threatening
arrhythmias, and channelopathies (disorders caused by the dysfunction of ion
channels).
- Clinically significant history of neurological, endocrinal (including thyrotoxicosis),
pulmonary, hematological, immunologic, gastrointestinal, renal, hepatic or metabolic
disease, or psychiatric illness other than ADHD.
- History of anxiety, tension, agitation, motor tics, Tourette's syndrome or a family
history (first-degree relatives) of Tourette's syndrome.
- History of glaucoma.
- Has a positive serum pregnancy test (if applicable) at screening.
- Positive findings on the Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal
ideation or behaviors at screening.
- Clinically significant illness or surgery within 4 weeks prior to dosing. Subjects who
experience vomiting within 24 hours prior to clinic admission will be carefully
evaluated for upcoming illness/disease.
- Hemoglobin <105 g/L or hematocrit <0.310 L/L at screening (subjects with abnormal
hemoglobin and/or hematocrit levels deemed not clinically significant may be included
in the study, at the discretion of the investigator).
- Subject has received anticonvulsants (eg, phenobarbital, phenytoin, primidone),
coumarin anticoagulants, prescription pressor agents, pressor agents, guanethidine,
tricyclic antidepressants (imipramine, desipramine, selective serotonin inhibitors) or
herbal remedies within 30 days prior to the first dosing, or melatonin within 3 days
prior to the first dosing.
Other protocol specific inclusion/exclusion criteria may apply.
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