Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)

Stopped early · Phase 3

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

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).

Key facts

Study ID

NCT03325894

Run by

Shire

People needed

141

Starts

2018-01-02

Expected to finish

2019-01-19

Last updated by the study team

2021-06-03

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Harmonex Neuroscience Research — Dothan, Alabama, United States
• PEWMD, PA, ARCSM, PLLC, PRP, Inc. — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• Riverside Medical Clinic — Riverside, California, United States
• Peninsula Research Associates - CRN — Rolling Hills, California, United States
• Pediatric Medical Associates — Sacramento, California, United States
• Care Research Center — Doral, Florida, United States
• Power MD Clinical Research Institute — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Acevedo Medical Group — Miami, Florida, United States
• Pharmacology Research, LLC — Miami, Florida, United States
• Scientific Clinical Research, Inc. — North Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Clinical Associates of Orlando, Llc — Orlando, Florida, United States
• GA Psychiatric Services, LLC. — Atlanta, Georgia, United States
• Buford Family Practice — Buford, Georgia, United States
• One Health Research Clinic, Inc. — Norcross, Georgia, United States
• Institute for Behavioral Medicine — Smyrna, Georgia, United States
• Advanced Clinical Research, Inc — Meridian, Idaho, United States
• Conventions Psychiatry and Counseling — Naperville, Illinois, United States
• Pedia Research, LLC — Evansville, Indiana, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Qualmedica Research LLC, DBA Pedia Research — Owensboro, Kentucky, United States
• Neuroscientific Insights — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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