Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Fixed-Dose, Efficacy, and Safety Study of SHP465 in Children Aged 6-12 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
1 other identifier
interventional
89
1 country
41
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SHP465 at 6.25 mg in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6-12 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2017
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2017
CompletedFirst Posted
Study publicly available on registry
October 30, 2017
CompletedStudy Start
First participant enrolled
December 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2018
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedJune 2, 2021
May 1, 2021
6 months
October 26, 2017
June 7, 2019
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4
Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consisted of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity or impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. Least square (LS) mean was calculated based on restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance type.
Baseline, Week 4
Secondary Outcomes (10)
Clinical Global Impression of Improvement (CGI-I) at Week 4
Week 4
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
From start of study drug administration up to follow-up (Week 5)
Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE)
From start of study drug administration up to follow-up (Week 5)
Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator
From start of study drug administration up to follow-up (Week 5)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator
From start of study drug administration up to follow-up (Week 5)
- +5 more secondary outcomes
Study Arms (2)
SHP465
EXPERIMENTALParticipants will be randomized to receive SHP465 capsule 6.25 milligram (mg) orally once daily for 4 weeks.
Placebo
PLACEBO COMPARATORParticipant will receive placebo matching to SHP465 capsule orally once daily for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participant is male or female aged 6-12 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (41)
Harmonex Neuroscience Research
Dothan, Alabama, 36303, United States
PEWMD, PA, ARCSM, PLLC, PRP, Inc.
Little Rock, Arkansas, 72211, United States
Advanced Research Center
Anaheim, California, 92805, United States
Riverside Medical Clinic
Riverside, California, 92506, United States
Peninsula Research Associates - CRN
Rolling Hills, California, 90274, United States
Care Research Center
Doral, Florida, 33166, United States
Power MD Clinical Research Institute
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Acevedo Medical Group
Miami, Florida, 33142, United States
Pharmacology Research, LLC
Miami, Florida, 33175, United States
Scientific Clinical Research Inc.
North Miami, Florida, 33161, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Clinical Associates of Orlando, Llc
Orlando, Florida, 32806, United States
GA Psychiatric Services, LLC.
Atlanta, Georgia, 30338-6520, United States
Buford Family Practice
Buford, Georgia, 30519, United States
One Health Research Clinic, Inc.
Norcross, Georgia, 30093, United States
Institute for Behavioral Medicine
Smyrna, Georgia, 30082, United States
Advanced Clinical Research Inc.
Meridian, Idaho, 83642, United States
Conventions Psychiatry and Counseling
Naperville, Illinois, 60563, United States
Pedia Research, LLC
Evansville, Indiana, 47715, United States
Psychiatric Associates
Overland Park, Kansas, 66211, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Neuroscientific Insights
Rockville, Maryland, 20852, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302, United States
St Charles Psychiatric Associates
Saint Charles, Missouri, 63304, United States
Triangle Neuropsychiatry
Durham, North Carolina, 27707, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, 44281, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Coastal Pediatric Associates
Charleston, South Carolina, 29414, United States
Coastal Pediatric Associates
Mt. Pleasant, South Carolina, 29464, United States
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203, United States
El Campo Clinical Trials
El Campo, Texas, 77437, United States
Houston Clinical Trials, LLC
Houston, Texas, 77098, United States
Children's Clinic
League City, Texas, 77573, United States
University of Texas
San Antonio, Texas, 78229-7822, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
VA South Psychiatric & Family Services
Petersburg, Virginia, 23805, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Mid-Columbia Research
Richland, Washington, 99352, United States
Related Publications (1)
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.
PMID: 33185468DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2017
First Posted
October 30, 2017
Study Start
December 9, 2017
Primary Completion
June 7, 2018
Study Completion
June 7, 2018
Last Updated
June 2, 2021
Results First Posted
August 13, 2019
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.