Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: amphetamine extended-release oral suspension, 2.5 mg/mL; Placebo extended-release oral suspension
Intervention description: 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO; 6, 7 or 8 mL PO
Intervention MeSH terms: Amphetamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study
Masking: Double (Participant, Investigator)
Masking description: placebo-controlled
Enrollment: 18.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine
      extended-release oral suspension, CII) for the treatment of symptoms of
      attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females aged 6 to 12 years at the time of screening, inclusive

          2. Diagnosed with ADHD by a psychiatrist within 6 months of study enrolment or newly
             diagnosed with ADHD using the DSM-5 criteria for ADHD

          3. An ADHD-RS-5 score at Screening ≥90th percentile for sex and age in at least one of
             the following categories:

               1. Hyperactive-impulsive subscale,

               2. Inattentive subscale, or

               3. 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.

          4. In the clinical judgment of the Investigator, the subject must be in need of
             pharmacological treatment for ADHD.

          5. Females of childbearing potential must be non-lactating and must have a negative serum
             pregnancy test at screening

          6. Provide written informed consent (parent/guardian) and assent (child aged 10 - 12
             years only) prior to participation in the study

        Exclusion Criteria:

          1. 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

          2. 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

          3. 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).

          4. Clinically significant abnormal ECG or cardiac findings on physical examination
             (including the presence of a pathologic murmur)

          5. 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)

          6. 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)

          7. Use of atomoxetine within 14 days of Baseline Visit

          8. Planned use of prohibited drugs or agents from the Screening visit through the end of
             the study

          9. Abnormal clinically significantly laboratory test value at screening that, in the
             opinion of the Investigator, would preclude study participation

         10. Known history of allergy/hypersensitivity to amphetamine or any of the components of
             Dyanavel XR, or topical anaesthetics

         11. Known history of lack of response to amphetamine

         12. Parent or guardian's inability or unwillingness to follow directions of the
             Investigator or study research staff.

         13. Any uncontrolled medical condition that in the opinion of the Investigator would
             preclude study participation

         14. History of significant illness requiring hospitalization, or surgery requiring
             anaesthetics within 30 days of Baseline Visit