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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03325894
Recruitment Status : Terminated (The study was stopped due to efficacy reasons.)
First Posted : October 30, 2017
Last Update Posted : April 23, 2019
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Drug: SHP465 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SHP465
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.
Drug: SHP465
SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.

Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 367 (Follow-up) ]
    An adverse event (AE) is 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 are 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.

  2. Number of Participants With Clinically Significant Change in Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 367 (Follow-up) ]
    Vital sign assessments include systolic and diastolic blood pressure, pulse, temperature, and respiratory rate. Any clinically significant deviations from baseline in vital signs that are deemed clinically significant in the opinion of the investigator are to be recorded as a TEAE.

  3. Measurement of Height [ Time Frame: Baseline up to Visit 16 (Day 360) ]
    Height will be measured in inches or centimeters without shoes.

  4. Measurement of Weight [ Time Frame: Baseline up to Visit 16 (Day 360) ]
    Weight will be measured in pounds or kilograms without shoes and with light clothing.

  5. Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event [ Time Frame: Baseline up to Day 367 (Follow-up) ]
    Clinical laboratory assessments include biochemistry and endocrinology, hematology and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant.

  6. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event [ Time Frame: Baseline up to Day 367 (Follow-up) ]
    12-lead ECG will be performed using the central ECG provider's equipment and will be sent to the central ECG provider electronically. Any clinically significant change in ECG assessment will be reported as AE.

  7. Post Sleep Questionnaire (PSQ) [ Time Frame: Baseline up to Visit 16 (Day 360) ]
    PSQ is a 7-item questionnaire typically used to assess sleep qualitywith 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.

  8. Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Baseline up to Visit 16 (Day 360) ]
    CSHQ is a tool designed to screen for the most common sleep problems in children and consists of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness.

  9. Columbia-suicide Severity Rating Scale (C-SSRS) [ Time Frame: Visit 3 (Day 7) up to Visit 16 (Day 360) ]
    C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period.

Secondary Outcome Measures :
  1. Change From Baseline in Clinician-administered Attention-deficit/Hyperactivity Disorder Rating Scale-5 (ADHDRS-5) Total Score [ Time Frame: Baseline, Visit 16 (Day 360) ]
    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 score represents more severe symptoms.

  2. Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Visit 3 (Day 7) up to Visit 16 (Day 360) ]
    CGI-I scale will be 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03325894

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Sponsors and Collaborators
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Study Director: Study Director Shire

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Responsible Party: Shire Identifier: NCT03325894     History of Changes
Other Study ID Numbers: SHP465-308
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the website. 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shire:
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms