Clinical trial NCT03325881: Efficacy and Safety of SHP465 at 6.25 mg in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
Hyperactivity
SHP465
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 89
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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 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.

Primary outcomes:
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Clinical Global Impression of Improvement (CGI-I) at Week 4
timeFrame: Week 4
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From start of study drug administration up to follow-up (Week 5)
measure: Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE)
timeFrame: From start of study drug administration up to follow-up (Week 5)
measure: Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator
timeFrame: From start of study drug administration up to follow-up (Week 5)
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator
timeFrame: From start of study drug administration up to follow-up (Week 5)
measure: Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by PSQ at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4
timeFrame: Baseline, Week 4
measure: Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4
timeFrame: Week 4
measure: Number of Participants With a Positive Response in Columbia-suicide Severity Rating Scale (C-SSRS) at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Little Rock
country: United States
facility: PEWMD, PA, ARCSM, PLLC, PRP, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Riverside
country: United States
facility: Riverside Medical Clinic
state: California
city: Rolling Hills
country: United States
facility: Peninsula Research Associates - CRN
state: California
city: Doral
country: United States
facility: Care Research Center
state: Florida
city: Hialeah
country: United States
facility: Power MD Clinical Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Acevedo Medical Group
state: Florida
city: Miami
country: United States
facility: Pharmacology Research, LLC
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando, Llc
state: Florida
city: Atlanta
country: United States
facility: GA Psychiatric Services, LLC.
state: Georgia
city: Buford
country: United States
facility: Buford Family Practice
state: Georgia
city: Norcross
country: United States
facility: One Health Research Clinic, Inc.
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research Inc.
state: Idaho
city: Naperville
country: United States
facility: Conventions Psychiatry and Counseling
state: Illinois
city: Evansville
country: United States
facility: Pedia Research, LLC
state: Indiana
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Rockville
country: United States
facility: Neuroscientific Insights
state: Maryland
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group
state: Michigan
city: Saint Charles
country: United States
facility: St Charles Psychiatric Associates
state: Missouri
city: Durham
country: United States
facility: Triangle Neuropsychiatry
state: North Carolina
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Nashville
country: United States
facility: Access Clinical Trials, Inc.
state: Tennessee
city: El Campo
country: United States
facility: El Campo Clinical Trials
state: Texas
city: Houston
country: United States
facility: Houston Clinical Trials, LLC
state: Texas
city: League City
country: United States
facility: Children's Clinic
state: Texas
city: San Antonio
country: United States
facility: University of Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Petersburg
country: United States
facility: VA South Psychiatric & Family Services
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Richland
country: United States
facility: Mid-Columbia Research
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.