Safety, Tolerability, Pharmacokinetic, and Efficacy Study of SPD489 in Preschool Children With Attention-deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: SPD489
Intervention description: All subjects will begin with 5mg of SPD489 daily and will be titrated until optimal dose is reached (5, 10, 15, 20, and 30mg)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to gain initial safety, tolerability, pharmacokinetic, and
      efficacy information on SPD489 in preschool children 4-5 years old who are diagnosed with
      ADHD. Generating such data will provide data on the use of SPD489 in the preschool ADHD
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is a male or female aged 4-5 years inclusive at the time of consent. Only
             recruiting male subjects as of December 2015

          2. Subject's parent or LAR must provide signature of informed consent, and there must be
             documentation of assent (if applicable) by the subject in accordance with the ICH GCP
             Guideline E6 (1996) and applicable regulations, before completing any study-related
             procedures.

          3. Subject and parent/LAR are willing and able to comply with all of the testing and
             requirements defined in the protocol, including oversight of morning dosing.
             Specifically, the same parent/LAR should be available daily to dispense the dose of
             investigational product for the study duration.

          4. Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD (all subtypes)
             based on a detailed psychiatric evaluation conducted by a sponsor-approved clinician

          5. Subject has an ADHD-RS-IV Preschool Version total score ≥93rd percentile at the
             Baseline Visit (Visit 0). For boys, this is a score of ≥32. For girls, this is a score
             of ≥24.

          6. Subject has a CGI-S score ≥4 at the Baseline Visit (Visit 0).

          7. Subject has a Peabody Picture Vocabulary Test, Fourth Edition standard score of ≥70 at
             the Screening Visit (Visit -1).

          8. Subject has undergone an adequate course of non-pharmacological treatment based on
             investigator judgment or the subject has a severe enough condition to consider
             enrollment without undergoing prior non-pharmacological treatment based on
             investigator judgment.

          9. Subject has, in the opinion of the investigator, participated in a structured group
             activity (e.g., preschool, sports, Sunday school) so as to assess symptoms and
             impairment in a setting outside the home.

         10. Subject has lived with the same parent/LAR for ≥6 months.

        Exclusion Criteria:

          1. Subject is required to or anticipates the need to take medications that have CNS
             effects or affect performance, such as sedating antihistamines and decongestant
             sympathomimetics, or are taking monoamine oxidase inhibitors. Stable use of
             bronchodilator inhalers is not exclusionary.

          2. Subject has taken another investigational product or has taken part in a clinical
             study within 30 days prior to the Screening Visit (Visit -1).

          3. Subject is well controlled on his/her current ADHD medication with acceptable
             tolerability.

          4. Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or
             an infectious process requiring antibiotics), disability, or other condition that
             might confound the results of safety assessments conducted in the study or that might
             increase risk to the subject. Similarly, the subject will be excluded if he or she has
             any additional condition(s) that, in the investigator's opinion, would prohibit the
             subject from completing the study or would not be in the best interest of the subject.
             The additional conditions would include any significant illness or unstable medical
             condition that could lead to difficulty complying with the protocol. Mild, stable
             asthma is not exclusionary.

          5. Subject has failed to fully respond, based on investigator judgment, to a previously
             administered adequate course of amphetamine therapy.

          6. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or
             to any excipients in the investigational product.

          7. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

          8. Subject has a blood pressure measurement ≥95th percentile for age, sex, and height at
             the Screening Visit (Visit -1) or the Baseline Visit (Visit 0).

          9. Subject has a known history of symptomatic cardiovascular disease, advanced
             arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm
             abnormalities, coronary artery disease, or other serious cardiac problems placing them
             at increased vulnerability to the sympathomimetic effects of a stimulant drug.

         10. Subject has any clinically significant electrocardiogram at the Screening Visit (Visit
             -1) or the Baseline Visit (Visit 0) or clinically significant laboratory abnormalities
             at the Screening Visit (Visit -1) based on investigator judgment.

         11. Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating
             hormone and thyroxine at the Screening Visit (Visit -1). Treatment with a stable dose
             of thyroid medication for at least 3 months is permitted.

         12. Subject has a current diagnosis of adjustment disorder, autism, psychosis, or bipolar
             disorder.

         13. Subject is currently considered at risk for suicide in the opinion of the
             investigator, has previously made a suicide attempt, or is currently demonstrating
             active suicidal ideation. Subjects with intermittent passive suicidal ideation are not
             necessarily excluded, based on the assessment of the investigator.

         14. Subject has a height ≤5th percentile for age and sex at the Screening Visit (Visit
             -1).

         15. Subject has a weight ≤5th percentile for age and sex at the Screening Visit (Visit
             -1).

         16. Subject has a history of seizures (other than infantile febrile seizures) or a current
             diagnosis of Tourette's disorder.

         17. Subject has a chronic or current tic disorder that is judged by the investigator to be
             exclusionary.

         18. Subject is taking any medication that is excluded.