Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
NCT ID: NCT03325881
Last Updated: 2021-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
89 participants
INTERVENTIONAL
2017-12-09
2018-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SHP465
Participants will be randomized to receive SHP465 capsule 6.25 milligram (mg) orally once daily for 4 weeks.
SHP465
SHP465 capsule 6.25 mg orally once daily for 4 weeks
Placebo
Participant will receive placebo matching to SHP465 capsule orally once daily for 4 weeks.
Placebo
Placebo matching to SHP465 capsule orally once daily for 4 weeks
Interventions
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SHP465
SHP465 capsule 6.25 mg orally once daily for 4 weeks
Placebo
Placebo matching to SHP465 capsule orally once daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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 has a current, controlled (requiring medication or therapy) or uncontrolled, comorbid psychiatric disorder.
* 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.
6 Years
12 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Pedia Research, LLC
Owensboro, Kentucky, United States
Neuroscientific Insights
Rockville, Maryland, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
St Charles Psychiatric Associates
Saint Charles, Missouri, United States
Triangle Neuropsychiatry
Durham, North Carolina, United States
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
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
Ohio Pediatric Research Association
Dayton, Ohio, United States
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
Coastal Pediatric Associates
Mt. Pleasant, South Carolina, United States
Access Clinical Trials, Inc.
Nashville, Tennessee, United States
El Campo Clinical Trials
El Campo, Texas, United States
Houston Clinical Trials, LLC
Houston, Texas, United States
Children's Clinic
League City, Texas, United States
University of Texas
San Antonio, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
VA South Psychiatric & Family Services
Petersburg, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Mid-Columbia Research
Richland, Washington, United States
Countries
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References
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Mattingly G, Arnold V, Yan B, Yu M, Robertson B. A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2020 Nov;30(9):549-557. doi: 10.1089/cap.2020.0005. Epub 2020 Oct 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SHP465-309
Identifier Type: -
Identifier Source: org_study_id
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