Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT03325894|
Recruitment Status : Terminated (The study was stopped due to efficacy reasons.)
First Posted : October 30, 2017
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder (ADHD)||Drug: SHP465||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.
- 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.
- 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.
- Measurement of Height [ Time Frame: Baseline up to Visit 16 (Day 360) ]Height will be measured in inches or centimeters without shoes.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT03325894
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|Study Director:||Study Director||Shire|