Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: SHP465
Intervention description: SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; SHP465; Hyperactivity

Summary:

      The purpose of the study is to evaluate the long-term safety and tolerability of SHP465 at
      6.25 milligram (mg) in children aged 4 to 12 years diagnosed with
      Attention-Deficit/Hyperactivity Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is male or female aged 4-12 years inclusive at the time of consent.

          -  Participant's parent or legally authorized representative (LAR) must provide signature
             of informed consent, and there must be documentation of assent (as applicable) by the
             participant.

          -  Participant must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5) criteria for a primary diagnosis of ADHD (any subtype).

          -  Participant who is a female and of child-bearing potential must not be pregnant and
             agree to comply with any applicable contraceptive requirements..

          -  Participant has an ADHD-RS-5 Child, Home Version Total Score of greater than or equal
             to (>=) 28 and Clinical Global Impression - Severity of Illness (CGI-S) score >=4 at
             baseline (Visit 2). Participant is currently not on ADHD therapy, or is not completely
             satisfied with their current ADHD therapy.

        Exclusion Criteria:

          -  Participant is required or anticipated to take medications that have central nervous
             system effects or affect performance. Stable use of bronchodilator inhalers is not
             exclusionary.

          -  Participant has a concurrent chronic or acute illness, disability, or other condition
             that might confound the results of safety assessments conducted in the study or that
             might increase risk to the participant. - Participant has a documented allergy,
             hypersensitivity, or intolerance to amphetamine or to any excipients in the
             investigational product.

          -  Participant has failed to fully respond, based on investigator judgment, to an
             adequate course of amphetamine therapy.

          -  Participant has a known family history of sudden cardiac death or ventricular
             arrhythmia.

          -  Participant has a blood pressure measurement >=95th percentile for age, sex, and
             height at screening (Visit 1) and/or baseline (Visit 2).

          -  Participant has a height less than or equal to (<=) 5th percentile for age and sex at
             screening (Visit 1) or baseline (Visit 2).

          -  Participant has a weight <=5th percentile for age and sex at screening (Visit 1) or
             baseline (Visit 2).

          -  Participant has a known history of symptomatic cardiovascular disease, structural
             cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, or other
             serious cardiac conditions placing them at increased vulnerability to the
             sympathomimetic effects of a stimulant drug.

          -  Participant has a history of seizures (other than infantile febrile seizures).

          -  Participant is taking any medication that is excluded per the protocol.

          -  Participant had any clinically significant ECG or clinical laboratory abnormalities at
             the screening (Visit 1) or baseline visit (Visit 2).

          -  Participant has current abnormal thyroid function, defined as abnormal
             thyroid-stimulating hormone and thyroxine at the screening or baseline visit.
             Treatment with a stable dose of thyroid medication for at least 3 months is permitted.

          -  Participant is currently considered a suicide risk in the opinion of the investigator,
             has previously made a suicide attempt, or has a prior history of or currently
             demonstrating suicidal ideation.