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)

Shire38 sites in 1 country89 target enrollmentDecember 9, 2017

ConditionsAttention Deficit Hyperactivity Disorder (ADHD)

InterventionsSHP465 Placebo

DrugsSHP465 Placebo

Overview

Phase: Phase 3
Intervention: SHP465
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Shire
Enrollment: 89
Locations: 38
Primary Endpoint: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 9, 2017

End Date

June 7, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

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).

Arms & Interventions

SHP465

Participants will be randomized to receive SHP465 capsule 6.25 milligram (mg) orally once daily for 4 weeks.

Intervention: SHP465

Placebo

Participant will receive placebo matching to SHP465 capsule orally once daily for 4 weeks.

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4

Time Frame: Baseline, 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.

Secondary Outcomes

Clinical Global Impression of Improvement (CGI-I) at Week 4(Week 4)
Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4(Baseline, Week 4)
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(Baseline, Week 4)
Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4(Baseline, Week 4)
Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4(Week 4)
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 a Positive Response in Columbia-suicide Severity Rating Scale (C-SSRS) 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 Electrocardiogram (ECG) Assessed by the Investigator(From start of study drug administration up to follow-up (Week 5))