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Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SHP465
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring ADHD, SHP465, Hyperactivity

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harmonex Neuroscience Research
  • PEWMD, PA, ARCSM, PLLC, PRP, Inc.
  • Advanced Research Center
  • Riverside Medical Clinic
  • Peninsula Research Associates - CRN
  • Pediatric Medical Associates
  • Care Research Center
  • Power MD Clinical Research Institute
  • Clinical Neuroscience Solutions, Inc.
  • Acevedo Medical Group
  • Pharmacology Research, LLC
  • Scientific Clinical Research, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Associates of Orlando, Llc
  • GA Psychiatric Services, LLC.
  • Buford Family Practice
  • One Health Research Clinic, Inc.
  • Institute for Behavioral Medicine
  • Advanced Clinical Research, Inc
  • Conventions Psychiatry and Counseling
  • Pedia Research, LLC
  • Psychiatric Associates
  • Kentucky Pediatric/Adult Research
  • Qualmedica Research LLC, DBA Pedia Research
  • Neuroscientific Insights
  • Neurobehavioral Medicine Group
  • St Charles Psychiatric Associates
  • Alivation Research, LLC.
  • Triangle Neuropsychiatry
  • University Hospitals Cleveland Medical Center
  • Ohio Pediatric Research Association
  • Professional Psychiatric Services
  • Family Practice Center of Wadsworth, INC.
  • IPS Research Company
  • Rainbow Research, Inc.
  • Coastal Pediatric Associates
  • Coastal Pediatric Associates
  • Clinical Neuroscience Solutions, Inc.
  • Access Clinical Trials, Inc.
  • El Campo Clinical Trials
  • Houston Clinical Trials, LLC
  • Children's Clinic
  • University of Texas
  • Family Psychiatry of the Woodlands
  • University of Virginia Health System
  • VA South Psychiatric & Family Services
  • Northwest Clinical Research Center
  • Mid-Columbia Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHP465

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product.
Change From Baseline in Pulse Rate at Final On-Treatment Assessment (FoTA)
Change from baseline in pulse rate at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Change From Baseline in Blood Pressure at Final On-Treatment Assessment (FoTA)
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Change From Baseline in Height at Final On-Treatment Assessment (FoTA)
Height was measured in centimeters (cm) without shoes and with light clothing using a stadiometer. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Change From Baseline in Weight at Final On-Treatment Assessment (FoTA)
Weight was measured in kilograms (kg) without shoes and with light clothing using a calibrated scale. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Change From Baseline in Hematology Parameters at Early Termination/Day 360
Change from baseline in hematology parameter basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils band form, segmented neutrophils, neutrophils/total cells and platelets were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Leukocytes at Early Termination/Day 360
Change from baseline in hematology leukocytes parameter: basophils, eosinophils, lymphocytes, monocytes and neutrophil were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Erythrocytes at Early Termination/Day 360
Change from baseline in hematology parameter erythrocytes were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin Concentration at Early Termination/Day 360
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin concentration were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Early Termination/Day 360
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Hematocrit at Early Termination/Day 360
Change from baseline in hematology parameter hematocrit were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Hemoglobin at Early Termination/Day 360
Change from baseline in hematology parameter hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Hematology Parameters (Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume) at Early Termination/ Day 360
Change from baseline in hematology parameter erythrocytes mean corpuscular volume and mean platelet volume were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Chemistry Parameters at Early Termination/Day 360
Change from baseline in chemistry parameter alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Early Termination/Day 360
Change from baseline in chemistry parameters albumin and protein were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Chemistry Parameters (Blood Urea Nitrogen, Cholesterol, Glucose, Phosphate, Potassium, Sodium and Urate) at Early Termination/Day 360
Change from baseline in chemistry parameters blood urea nitrogen, cholesterol, glucose, phosphate, potassium, sodium and urate were studies. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Chemistry Parameters (Bilirubin and Creatinine) at Early Termination/Day 360
Change from baseline in chemistry parameters bilirubin and creatinine were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Thyrotropin at Early Termination/ Day 360
Change from baseline in thyrotropin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Thyroxine,Free at Early Termination/Day 360
Change from baseline in thyroxine,free were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Urinalysis (Specific Gravity) at Early Termination/Day 360
Change from baseline in urine specific gravity were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Urobilinogen at Early Termination/Day 360
Change from baseline in urobilinogen were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Urine Potential of Hydrogen (pH) at Early Termination/Day 360
Change from baseline in urine pH were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Change From Baseline in Heart Rate at Final On-Treatment Assessment (FoTA)
Heart rate was measured by Electrocardiogram (ECG). ECG was performed using the central ECG provider's equipment and was send to the central ECG provider electronically. Change from baseline in heart rate at FoTA were reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
Change From Baseline in Electrocardiogram Parameters at Final On-Treatment Assessment (FoTA)
ECG was performed using the central ECG provider's equipment and was sent to the central ECG provider electronically to measure PR, RR, QRS , QT, QTcB and QTcF intervals. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. The assessment was done by the nature of the responses, not by a numbered scale. Participants analyzed for number of times woke up per night category were only the participants who responded as yes for the woke up during the night category in this outcome measure. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
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)
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time awake per night and length of time to fall asleep per night was assessed at FoTA.
Length of Time Sleeping Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time sleeping per night was assessed at FoTA.
Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment (FoTA)
CSHQ was a tool designed to screen for the most common sleep problems in children and consisted of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the 8 different subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. A 3-point scale was used for rating: "usually" if the sleep behavior occurs 5 to 7 times per week, "sometimes" for 2 to 4 times per week, and "rarely" for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance.
Number of Participants With a Positive Response in Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 330
C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The number of participants with postive response in suicidal ideation and suicidal behavior were reported.

Secondary Outcome Measures

Change From Baseline in Clinician-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Final On-Treatment Assessment (FoTA)
Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consists 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 is 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 may be grouped into 2 subscales: hyperactivity/impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).
Clinical Global Impression of Improvement (CGI-I) at Final On-Treatment Assessment (FoTA)
CGI-I scale was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date).

Full Information

First Posted
October 26, 2017
Last Updated
May 13, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT03325894
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to efficacy reasons.
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 19, 2019 (Actual)
Study Completion Date
January 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
ADHD, SHP465, Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHP465
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SHP465
Intervention Description
SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product.
Time Frame
From start of study drug administration up to follow-up (approximately up to 367 days)
Title
Change From Baseline in Pulse Rate at Final On-Treatment Assessment (FoTA)
Description
Change from baseline in pulse rate at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time Frame
Baseline, FoTA (up to 330 days)
Title
Change From Baseline in Blood Pressure at Final On-Treatment Assessment (FoTA)
Description
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time Frame
Baseline, FoTA (up to 330 days)
Title
Change From Baseline in Height at Final On-Treatment Assessment (FoTA)
Description
Height was measured in centimeters (cm) without shoes and with light clothing using a stadiometer. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time Frame
Baseline, FoTA (up to 330 days)
Title
Change From Baseline in Weight at Final On-Treatment Assessment (FoTA)
Description
Weight was measured in kilograms (kg) without shoes and with light clothing using a calibrated scale. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.
Time Frame
Baseline, FoTA (up to 330 days)
Title
Change From Baseline in Hematology Parameters at Early Termination/Day 360
Description
Change from baseline in hematology parameter basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils band form, segmented neutrophils, neutrophils/total cells and platelets were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Leukocytes at Early Termination/Day 360
Description
Change from baseline in hematology leukocytes parameter: basophils, eosinophils, lymphocytes, monocytes and neutrophil were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Erythrocytes at Early Termination/Day 360
Description
Change from baseline in hematology parameter erythrocytes were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin Concentration at Early Termination/Day 360
Description
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin concentration were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Early Termination/Day 360
Description
Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Hematocrit at Early Termination/Day 360
Description
Change from baseline in hematology parameter hematocrit were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Hemoglobin at Early Termination/Day 360
Description
Change from baseline in hematology parameter hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Hematology Parameters (Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume) at Early Termination/ Day 360
Description
Change from baseline in hematology parameter erythrocytes mean corpuscular volume and mean platelet volume were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Chemistry Parameters at Early Termination/Day 360
Description
Change from baseline in chemistry parameter alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Chemistry Parameters (Albumin and Protein) at Early Termination/Day 360
Description
Change from baseline in chemistry parameters albumin and protein were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Chemistry Parameters (Blood Urea Nitrogen, Cholesterol, Glucose, Phosphate, Potassium, Sodium and Urate) at Early Termination/Day 360
Description
Change from baseline in chemistry parameters blood urea nitrogen, cholesterol, glucose, phosphate, potassium, sodium and urate were studies. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Chemistry Parameters (Bilirubin and Creatinine) at Early Termination/Day 360
Description
Change from baseline in chemistry parameters bilirubin and creatinine were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Thyrotropin at Early Termination/ Day 360
Description
Change from baseline in thyrotropin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Thyroxine,Free at Early Termination/Day 360
Description
Change from baseline in thyroxine,free were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Urinalysis (Specific Gravity) at Early Termination/Day 360
Description
Change from baseline in urine specific gravity were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Urobilinogen at Early Termination/Day 360
Description
Change from baseline in urobilinogen were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early termination/Day 360
Title
Change From Baseline in Urine Potential of Hydrogen (pH) at Early Termination/Day 360
Description
Change from baseline in urine pH were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
Baseline, Early Termination/Day 360
Title
Change From Baseline in Heart Rate at Final On-Treatment Assessment (FoTA)
Description
Heart rate was measured by Electrocardiogram (ECG). ECG was performed using the central ECG provider's equipment and was send to the central ECG provider electronically. Change from baseline in heart rate at FoTA were reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
Time Frame
Baseline, FoTA (up to 330 days)
Title
Change From Baseline in Electrocardiogram Parameters at Final On-Treatment Assessment (FoTA)
Description
ECG was performed using the central ECG provider's equipment and was sent to the central ECG provider electronically to measure PR, RR, QRS , QT, QTcB and QTcF intervals. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.
Time Frame
Baseline, FoTA (up to 330 days)
Title
Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
Description
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. The assessment was done by the nature of the responses, not by a numbered scale. Participants analyzed for number of times woke up per night category were only the participants who responded as yes for the woke up during the night category in this outcome measure. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.
Time Frame
FoTA (up to 330 days)
Title
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)
Description
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time awake per night and length of time to fall asleep per night was assessed at FoTA.
Time Frame
FoTA (up to 330 days)
Title
Length of Time Sleeping Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)
Description
PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time sleeping per night was assessed at FoTA.
Time Frame
FoTA (up to 330 days)
Title
Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment (FoTA)
Description
CSHQ was a tool designed to screen for the most common sleep problems in children and consisted of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the 8 different subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. A 3-point scale was used for rating: "usually" if the sleep behavior occurs 5 to 7 times per week, "sometimes" for 2 to 4 times per week, and "rarely" for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance.
Time Frame
FoTA (up to 330 days)
Title
Number of Participants With a Positive Response in Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 330
Description
C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The number of participants with postive response in suicidal ideation and suicidal behavior were reported.
Time Frame
Day 330
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinician-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Final On-Treatment Assessment (FoTA)
Description
Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consists 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 is 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 may be grouped into 2 subscales: hyperactivity/impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).
Time Frame
Baseline, FoTA (up to 330 days)
Title
Clinical Global Impression of Improvement (CGI-I) at Final On-Treatment Assessment (FoTA)
Description
CGI-I scale was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date).
Time Frame
FoTA (up to 330 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
PEWMD, PA, ARCSM, PLLC, PRP, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Advanced Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Riverside Medical Clinic
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Peninsula Research Associates - CRN
City
Rolling Hills
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Pediatric Medical Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Care Research Center
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Power MD Clinical Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Acevedo Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Pharmacology Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33175-0000
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Associates of Orlando, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GA Psychiatric Services, LLC.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338-6520
Country
United States
Facility Name
Buford Family Practice
City
Buford
State/Province
Georgia
ZIP/Postal Code
30519
Country
United States
Facility Name
One Health Research Clinic, Inc.
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Facility Name
Institute for Behavioral Medicine
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082
Country
United States
Facility Name
Advanced Clinical Research, Inc
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Conventions Psychiatry and Counseling
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Pedia Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Psychiatric Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Kentucky Pediatric/Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Qualmedica Research LLC, DBA Pedia Research
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Neuroscientific Insights
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Neurobehavioral Medicine Group
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
St Charles Psychiatric Associates
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Alivation Research, LLC.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526-9467
Country
United States
Facility Name
Triangle Neuropsychiatry
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio Pediatric Research Association
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Professional Psychiatric Services
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Family Practice Center of Wadsworth, INC.
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281-0000
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Rainbow Research, Inc.
City
Barnwell
State/Province
South Carolina
ZIP/Postal Code
29812
Country
United States
Facility Name
Coastal Pediatric Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Coastal Pediatric Associates
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Access Clinical Trials, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
El Campo Clinical Trials
City
El Campo
State/Province
Texas
ZIP/Postal Code
77437
Country
United States
Facility Name
Houston Clinical Trials, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Children's Clinic
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
University of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-7822
Country
United States
Facility Name
Family Psychiatry of the Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
VA South Psychiatric & Family Services
City
Petersburg
State/Province
Virginia
ZIP/Postal Code
23805
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Mid-Columbia Research
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)

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