safety and tolerability study of shp465 in children aged 4 to 12 years diagnosed with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

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.

Keywords: adhd shp465 hyperactivity