Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: SHP465; Placebo
Intervention description: 12.5mg and 25mg capsules (one capsule daily); Matching placebo capsule that appear identical in size, weight, shape, color
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD
      in children and adolescents (aged 6-17 years). The primary objective of this study is to
      evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in
      the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must be 6-17 years of age, inclusive, at the time of consent.

          2. Subject's parent or legally authorized representative (LAR) must provide signature of
             informed consent, and there must be documentation of assent (if applicable) by the
             subject indicating that the subject is aware of the investigational nature of the
             study and the required procedures and restrictions 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 parent/LAR must be available at approximately 7:00AM (±2 hours) to
             dispense the dose of investigational product for the study duration.

          4. Subject, who is a female and of child-bearing potential, must not have a positive
             serum beta human chorionic gonadotropin pregnancy test at the Screening Visit (Visit
             1) and must have a negative urine pregnancy test at the Baseline Visit (Visit 2) and
             agree to comply with any applicable contraceptive requirements of the protocol.

          5. Subject must have a satisfactory medical assessment with no clinically significant or
             relevant abnormalities.

          6. Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed
             psychiatric evaluation.

          7. Subject has an ADHD-RS-IV Total Score >28 at the Baseline Visit (Visit 2).

          8. Subject is functioning at an age-appropriate level intellectually, as determined by
             the study Investigator.

          9. Subject is currently not on ADHD therapy, or is not completely satisfied with any
             aspect of their current ADHD therapy.

         10. Subject is able to swallow a capsule whole.

        Exclusion Criteria:

          1. Subject has a current, controlled (with medications prohibited in this study) or
             uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any
             significant comorbid Axis II disorder or significant Axis I disorder (such as
             post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental
             disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or
             other symptomatic manifestations that, in the opinion of the examining clinician, will
             contraindicate treatment with SHP465 or confound efficacy or safety assessments.
             Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit 1)
             interview of the K-SADS-PL and additional modules if warranted by the results of the
             initial interview. Subjects may continue participation in a behavioral modification
             program during the study as long as they have been participating in the program for at
             least 1 month at the time of the Baseline Visit (Visit 2).

          2. Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder
             is not exclusionary.

          3. Subject is considered a suicide risk 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.

          4. Subject is underweight based on Centers for Disease Control and Prevention body mass
             index (BMI)-for-age sex-specific values at the Screening Visit (Visit 1). Underweight
             is defined as a BMI <3rd percentile

          5. Subject is significantly overweight based on Centers for Disease Control and
             Prevention BMI-for-age sex specific values at the Screening Visit (Visit 1).
             Significantly overweight is defined as a BMI >97th percentile for this study

          6. 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.

          7. Subject has a history of seizure (other than infantile febrile seizures), a chronic or
             current tic disorder, or a current diagnosis of Tourette's Disorder. Subject has a
             history of tics that are judged by the Investigator to be exclusionary.

          8. Subject's blood pressure measurements exceed the 90th percentile for age, sex, and
             height (based on the Blood Pressure Levels by Age and Height Percentile [for boys and
             girls]) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2)

          9. Subject has a known history of hypertension

         10. 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 that may
             place him/her at increased vulnerability to the sympathomimetic effects of a stimulant
             medication.

         11. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

         12. Subject has any clinically significant ECG or clinically significant laboratory
             abnormality at the Screening Visit (Visit 1).

         13. 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.

         14. Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or
             to any excipients in the investigational product.

         15. Subject has failed to respond, based on Investigator judgment, to an adequate
             course(s) (dose and duration) of amphetamine therapy

         16. Subject has a history of suspected substance abuse or dependence disorder (excluding
             nicotine) in accordance with DSM-IV-TR criteria. Subjects with a lifetime history of
             amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.

         17. Subject has a positive urine drug result at the Screening Visit (Visit 1) (with the
             exception of subject's current stimulant therapy, if any) or the Baseline Visit (Visit
             2), if repeated unless the Investigator can verify that the positive result at the
             Screening Visit (Visit 1) is attributed to medication that has been prescribed to the
             subject and will be discontinued prior to the Baseline Visit (Visit 2). A positive
             result at the Screening Visit (Visit 1) attributed to a prescribed medication requires
             a re-test and a negative result at the Baseline Visit (Visit 2) to confirm subject
             eligibility.

         18. Subject has taken another investigational product or has taken part in a clinical
             study within 30 days prior to the Screening Visit (Visit 1).

         19. Subject has previously completed, discontinued, or was withdrawn from this study.

         20. Subject is taking any medication that is excluded or has not been appropriately washed
             out according to the protocol requirements.

         21. Subject is required to take or anticipates the need to take medications that have
             central nervous system effects or affect performance, such as sedating antihistamines
             and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of
             bronchodilator inhalers is not exclusionary.

         22. Subject is female and is pregnant or lactating