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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHP465 | Experimental | Participants will be randomized to receive SHP465 capsule 6.25 milligram (mg) orally once daily for 4 weeks. |
|
| Placebo | Placebo Comparator | Participant will receive placebo matching to SHP465 capsule orally once daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHP465 | Drug | SHP465 capsule 6.25 mg orally once daily for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at 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. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Improvement (CGI-I) at Week 4 | CGI scale was measured to rate the overall improvement of a participants condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). LS mean was calculated based on restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance type. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | United States | ||
| PEWMD, PA, ARCSM, PLLC, PRP, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33185468 | Derived | Mattingly G, Arnold V, Yan B, Yu M, Robertson B. A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2020 Nov;30(9):549-557. doi: 10.1089/cap.2020.0005. Epub 2020 Oct 13. |
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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.
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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.
A total of 124 participants were screened, of them 89 were randomized and 88 received the treatment. Out of them, 83 participants completed the study.
The study was conducted at 43 study centers in the United States between 09 December 2017 (first participant first visit) and 07 June 2018 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks. |
| FG001 | SHP465 | Participants received 6.25 milligrams (mg) SHP465 capsule orally once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2017 | Jul 19, 2019 |
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| Placebo |
| Drug |
Placebo matching to SHP465 capsule orally once daily for 4 weeks |
|
| 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 were 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. | From start of study drug administration up to follow-up (Week 5) |
| Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | Vital sign assessments included systolic and diastolic blood pressure and pulse. Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered as AE's. An 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. | 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 | Clinical laboratory tests included biochemistry, endocrinology, hematology and urinalysis. The investigator assessed out-of-range clinical laboratory values for clinical significance, if the value(s) were not clinically significant or clinically significant. | 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 | Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered in 12-lead ECG and reported. | From start of study drug administration up to follow-up (Week 5) |
| Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected 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. 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. | 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 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected 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. | Baseline, Week 4 |
| Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected 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. | Baseline, Week 4 |
| Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4 | The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. Parents were asked to think of a recent "typical" week of their child's sleep and to indicate how often sleep disturbance behaviors occurred. 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. | Week 4 |
| Number of Participants With a Positive Response in Columbia-suicide Severity Rating Scale (C-SSRS) at Week 4 | C-SSRS was 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 clinical significant change in suicidal ideation and suicidal behavior were reported. | Week 4 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Advanced Research Center | Anaheim | California | 92805 | United States |
| Riverside Medical Clinic | Riverside | California | 92506 | United States |
| Peninsula Research Associates - CRN | Rolling Hills | California | 90274 | United States |
| Care Research Center | Doral | Florida | 33166 | United States |
| Power MD Clinical Research Institute | Hialeah | Florida | 33012 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Acevedo Medical Group | Miami | Florida | 33142 | United States |
| Pharmacology Research, LLC | Miami | Florida | 33175 | United States |
| Scientific Clinical Research Inc. | North Miami | Florida | 33161 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Clinical Associates of Orlando, Llc | Orlando | Florida | 32806 | United States |
| GA Psychiatric Services, LLC. | Atlanta | Georgia | 30338-6520 | United States |
| Buford Family Practice | Buford | Georgia | 30519 | United States |
| One Health Research Clinic, Inc. | Norcross | Georgia | 30093 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30082 | United States |
| Advanced Clinical Research Inc. | Meridian | Idaho | 83642 | United States |
| Conventions Psychiatry and Counseling | Naperville | Illinois | 60563 | United States |
| Pedia Research, LLC | Evansville | Indiana | 47715 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Pedia Research, LLC | Owensboro | Kentucky | 42301 | United States |
| Neuroscientific Insights | Rockville | Maryland | 20852 | United States |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| St Charles Psychiatric Associates | Saint Charles | Missouri | 63304 | United States |
| Triangle Neuropsychiatry | Durham | North Carolina | 27707 | United States |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | United States |
| Family Practice Center of Wadsworth, Inc. | Wadsworth | Ohio | 44281 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | United States |
| Coastal Pediatric Associates | Mt. Pleasant | South Carolina | 29464 | United States |
| Access Clinical Trials, Inc. | Nashville | Tennessee | 37203 | United States |
| El Campo Clinical Trials | El Campo | Texas | 77437 | United States |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | United States |
| Children's Clinic | League City | Texas | 77573 | United States |
| University of Texas | San Antonio | Texas | 78229-7822 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| VA South Psychiatric & Family Services | Petersburg | Virginia | 23805 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Mid-Columbia Research | Richland | Washington | 99352 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Safety set consisted of all participants in the randomized set who took at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks. |
| BG001 | SHP465 | Participants received 6.25 mg SHP465 capsule orally once daily for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at 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. | Full analysis set consisted of all participants in the safety set who had baseline ADHD-RS-5 total score and at least 1 postdose ADHD-RS-5 total score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline, Week 4 |
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| Secondary | Clinical Global Impression of Improvement (CGI-I) at Week 4 | CGI scale was measured to rate the overall improvement of a participants condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). LS mean was calculated based on restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance type. | Full analysis set consisted of all participants in the safety set who had baseline ADHD-RS-5 total score and at least 1 postdose ADHD-RS-5 total score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Week 4 |
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| Secondary | 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 were 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. | Safety set consisted of all participants in the randomized set who as taken at least 1 dose of investigator product. | Posted | Count of Participants | Participants | From start of study drug administration up to follow-up (Week 5) |
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| Secondary | Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE) | Vital sign assessments included systolic and diastolic blood pressure and pulse. Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered as AE's. An 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. | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. | Posted | Count of Participants | Participants | From start of study drug administration up to follow-up (Week 5) |
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| Secondary | Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator | Clinical laboratory tests included biochemistry, endocrinology, hematology and urinalysis. The investigator assessed out-of-range clinical laboratory values for clinical significance, if the value(s) were not clinically significant or clinically significant. | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. | Posted | Count of Participants | Participants | From start of study drug administration up to follow-up (Week 5) |
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| Secondary | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator | Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered in 12-lead ECG and reported. | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. | Posted | Count of Participants | Participants | From start of study drug administration up to follow-up (Week 5) |
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| Secondary | Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected 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. 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. | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Count of Participants | Participants | Baseline, Week 4 |
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| Secondary | 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 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected 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. | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | minutes | Baseline, Week 4 |
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| Secondary | Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4 | The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected 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. | Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | hours | Baseline, Week 4 |
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| Secondary | Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4 | The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. Parents were asked to think of a recent "typical" week of their child's sleep and to indicate how often sleep disturbance behaviors occurred. 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. | Safety set consisted of all participants in the randomized set who took at least 1 dose of SHP465. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | Units on scale | Week 4 |
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| Secondary | Number of Participants With a Positive Response in Columbia-suicide Severity Rating Scale (C-SSRS) at Week 4 | C-SSRS was 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 clinical significant change in suicidal ideation and suicidal behavior were reported. | Safety set consisted of all participants in the randomized set who took at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point. | Posted | Count of Participants | Participants | Week 4 |
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From start of study drug administration up to follow-up (Week 5)
Safety analysis was analysed for the safety population (88 participants) and not for the enrolled population as in participant flow (89 participants).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participant received placebo matched to SHP465 capsule orally once daily for 4 weeks. | 0 | 43 | 0 | 43 | 3 | 43 |
| EG001 | SHP465 | Participants received 6.25 milligram (mg) of SHP465 capsule orally once daily for 4 weeks. | 0 | 45 | 0 | 45 | 2 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2018 | Jul 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| American Indian or Alaska Native |
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| Other |
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| Participants |
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