Clinical trial NCT03325894: Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
Official title: A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
SHP465
Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 141
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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.

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 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: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From start of study drug administration up to follow-up (approximately up to 367 days)
measure: Change From Baseline in Pulse Rate at Final On-Treatment Assessment (FoTA)
timeFrame: Baseline, FoTA (up to 330 days)
measure: Change From Baseline in Blood Pressure at Final On-Treatment Assessment (FoTA)
timeFrame: Baseline, FoTA (up to 330 days)
measure: Change From Baseline in Height at Final On-Treatment Assessment (FoTA)
timeFrame: Baseline, FoTA (up to 330 days)
measure: Change From Baseline in Weight at Final On-Treatment Assessment (FoTA)
timeFrame: Baseline, FoTA (up to 330 days)
measure: Change From Baseline in Hematology Parameters at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Leukocytes at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Erythrocytes at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin Concentration at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Hematocrit at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Hemoglobin at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Hematology Parameters (Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume) at Early Termination/ Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Chemistry Parameters at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Chemistry Parameters (Albumin and Protein) at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Chemistry Parameters (Blood Urea Nitrogen, Cholesterol, Glucose, Phosphate, Potassium, Sodium and Urate) at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Chemistry Parameters (Bilirubin and Creatinine) at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Thyrotropin at Early Termination/ Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Thyroxine,Free at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Urinalysis (Specific Gravity) at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Urobilinogen at Early Termination/Day 360
timeFrame: Baseline, Early termination/Day 360
measure: Change From Baseline in Urine Potential of Hydrogen (pH) at Early Termination/Day 360
timeFrame: Baseline, Early Termination/Day 360
measure: Change From Baseline in Heart Rate at Final On-Treatment Assessment (FoTA)
timeFrame: Baseline, FoTA (up to 330 days)
measure: Change From Baseline in Electrocardiogram Parameters at Final On-Treatment Assessment (FoTA)
timeFrame: Baseline, FoTA (up to 330 days)
measure: Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
timeFrame: FoTA (up to 330 days)
measure: Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
timeFrame: FoTA (up to 330 days)
measure: Length of Time Sleeping Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
timeFrame: FoTA (up to 330 days)
measure: Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment (FoTA)
timeFrame: FoTA (up to 330 days)
measure: Number of Participants With a Positive Response in Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 330
timeFrame: Day 330
Secondary outcomes:
measure: Change From Baseline in Clinician-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Final On-Treatment Assessment (FoTA)
timeFrame: Baseline, FoTA (up to 330 days)
measure: Clinical Global Impression of Improvement (CGI-I) at Final On-Treatment Assessment (FoTA)
timeFrame: FoTA (up to 330 days)
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: Sacramento
country: United States
facility: Pediatric Medical Associates
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: Qualmedica Research LLC, DBA Pedia Research
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: Lincoln
country: United States
facility: Alivation Research, LLC.
state: Nebraska
city: Durham
country: United States
facility: Triangle Neuropsychiatry
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Mason
country: United States
facility: Professional Psychiatric Services
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: Barnwell
country: United States
facility: Rainbow Research, Inc.
state: South Carolina
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: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
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: The Woodlands
country: United States
facility: Family Psychiatry of the Woodlands
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: