Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: SHP465 12.5mg capsules (one capsule daily); Placebo; SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)
Intervention description: one capsule daily; Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily); One capsule daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and
      37.5 mg) given to participants daily in the morning compared to placebo in the treatment of
      adults aged 18 to 55 years diagnosed with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must be 18-55 years of age

        Subject is able to provide written, personally signed and dated informed consent.

        Subject is willing and able to comply with all of the testing and requirements defined in
        the protocol

        Subject, who is a female, must not be pregnant.

        Subject must have a satisfactory medical assessment with no clinically significant or
        relevant abnormalities.

        Subject has a primary diagnosis of ADHD.

        Subject has an adult ADHD-RS with prompts total score ≥28 at the baseline visit.

        Subject must have a minimum level of intellectual functioning, as determined by the
        investigator.

        Subject is able to swallow a capsule.

        Subject is currently not on ADHD therapy or is not completely satisfied with any aspect of
        their current ADHD therapy.

        Exclusion Criteria:

        Subject has a current, comorbid psychiatric diagnosis with significant symptoms.

        Subject is considered a suicide risk in the opinion of the investigator

        Subject has a body mass index (BMI) of <18.5 kg/m2 at the screening visit.

        Subject has a BMI ≥40 kg/m2 at the screening visit.

        Subject has a concurrent chronic or acute illness, disability, or other condition.

        Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis
        of Tourette's disorder.

        Subject has a history of moderate to severe hypertension.

        Subject has a known history of symptomatic cardiovascular disease

        Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

        Subject has any clinically significant ECG or clinically significant laboratory abnormality
        at the screening visit.

        Subject has current abnormal thyroid function

        Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any
        excipients in the investigational product.

        Subject has failed to respond, to an adequate course(s) of amphetamine therapy.

        Subject has a history of suspected substance abuse or dependence disorder.

        Subject has a positive urine drug result at the screening visit (with the exception of
        subject's current stimulant therapy, if any) or Subject has taken another investigational
        product or has taken part in a clinical study within 30 days prior to the screening visit.

        Subject has previously completed, has discontinued, or was withdrawn from this study.

        Subject is taking any medication that is excluded or has not been appropriately washed out
        according to the protocol requirements.

        Subject is required to take or anticipates the need to take medications that have CNS
        effects or affect performance.

        Subject is female and is pregnant or lactating.