Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT03325894
Last Updated: 2021-06-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
141 participants
INTERVENTIONAL
2018-01-02
2019-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHP465
Group A participants who have been rolled-over from antecedent SHP465 studies and Group B participants who will be newly enrolled into the study will receive SHP465 capsule 6.25 mg orally once daily for 360 days.
SHP465
SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.
Interventions
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SHP465
SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.
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 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.
4 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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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
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
St Charles Psychiatric Associates
Saint Charles, Missouri, United States
Alivation Research, LLC.
Lincoln, Nebraska, United States
Triangle Neuropsychiatry
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Professional Psychiatric Services
Mason, Ohio, United States
Family Practice Center of Wadsworth, INC.
Wadsworth, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Rainbow Research, Inc.
Barnwell, South Carolina, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
Coastal Pediatric Associates
Mt. Pleasant, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 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
Family Psychiatry of the Woodlands
The Woodlands, 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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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SHP465-308
Identifier Type: -
Identifier Source: org_study_id
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