Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study

This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.

Inclusion criteria

• Males or females aged 6 to 12 years at the time of screening, inclusive
• Diagnosed with ADHD by a psychiatrist within 6 months of study enrolment or newly diagnosed with ADHD using the DSM-5 criteria for ADHD
• An ADHD-RS-5 score at Screening ≥90th percentile for sex and age in at least one of the following categories:

• Hyperactive-impulsive subscale,
• Inattentive subscale, or
• Total score. Subjects who do not meet this criteria at screening can have ADHD-RS-5 repeated at baseline, after washout of stimulant medication for a minimum of 24 hours prior to baseline.
• In the clinical judgment of the Investigator, the subject must be in need of pharmacological treatment for ADHD.
• Females of childbearing potential must be non-lactating and must have a negative serum pregnancy test at screening
• Provide written informed consent (parent/guardian) and assent (child aged 10 - 12 years only) prior to participation in the study

Exclusion criteria

• Diagnosed with any DSM-5 active disorder (other than ADHD) with the exception of specific phobias, learning disorders, motor skills disorders, communication disorders, oppositional defiant disorder, elimination disorders, and sleep disorders
• Known history of chronic medical illnesses including severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, known family history of sudden death
• Known history or presence of significant renal or hepatic disease, as indicated by clinical laboratory assessment (liver function test results ≥ two times the upper limit of normal, blood urea nitrogen, or creatinine).
• Clinically significant abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
• Use of the following medications within 30 days of Baseline Visit:

• MAOI - monoamine oxidase inhibitors (e.g., Selegiline, isocarboxazid, phenelzine, tranylcypromine)
• Tricyclic Antidepressants (e.g. Desipramine, protriptyline)
• Use of the following medications within 3 days of Baseline Visit

• Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid)
• Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts)
• Use of atomoxetine within 14 days of Baseline Visit
• Planned use of prohibited drugs or agents from the Screening visit through the end of the study
• Abnormal clinically significantly laboratory test value at screening that, in the opinion of the Investigator, would preclude study participation
• Known history of allergy/hypersensitivity to amphetamine or any of the components of Dyanavel XR, or topical anaesthetics
• Known history of lack of response to amphetamine
• Parent or guardian's inability or unwillingness to follow directions of the Investigator or study research staff.
• Any uncontrolled medical condition that in the opinion of the Investigator would preclude study participation
• History of significant illness requiring hospitalization, or surgery requiring anaesthetics within 30 days of Baseline Visit