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The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHP465 | Experimental | Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) |
|
| Placebo | Placebo Comparator | Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHP465 | Drug | 12.5mg and 25mg capsules (one capsule daily) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) 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 (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms. | Baseline, Visit 6 (Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4) | CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | Visit 6 (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 | ||
| Nrc Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28816509 | Result | Brams M, Childress AC, Greenbaum M, Yu M, Yan B, Jaffee M, Robertson B. SHP465 Mixed Amphetamine Salts in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results of a Randomized, Double-Blind Placebo-Controlled Study. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):19-28. doi: 10.1089/cap.2017.0053. Epub 2017 Aug 17. |
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A total of 338 participants were screened and 264 participants were enrolled in the study.
The study was conducted at 36 sites in the United States between 18 June 2015 and 16 February 2016.
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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 SHP465 capsule (12.5 milligram [mg] during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Matching placebo capsule that appear identical in size, weight, shape, color |
|
| Orange |
| California |
| 92868 |
| United States |
| Pcsd Feighner Research | San Diego | California | 92108 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Elite Clinical Trials, Inc | Wildomar | California | 92595 | United States |
| McB Clinical Research Centers | Colorado Springs | Colorado | 80910 | United States |
| Florida Clinical Research Center, Llc | Bradenton | Florida | 34201 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Miami Research Associates, Llc | South Miami | Florida | 33143 | United States |
| Janus Center For Psychiatric Research | West Palm Beach | Florida | 33407 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Baber Research Group Inc | Naperville | Illinois | 60563 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Louisiana Research Associates, Inc | New Orleans | Louisiana | 70114 | United States |
| Rochester Center For Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | United States |
| Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Center For Psychiatry and Behavioral Medicine | Las Vegas | Nevada | 89128 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Tulsa Clinical Research, Llc | Tulsa | Oklahoma | 74104 | United States |
| Oregon Center For Clinical Investigations, Inc | Salem | Oregon | 97301 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Rainbow Research | Barnwell | South Carolina | 29812 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Neuroscience Solution, Inc | Memphis | Tennessee | 38119 | United States |
| Futuresearch Trials of Dallas, Lp | Dallas | Texas | 75231 | United States |
| Bayou City Research | Houston | Texas | 77007 | United States |
| Red Oak Psychiatry Associates, Pa | Houston | Texas | 77090 | United States |
| Houston Clinical Trials, Llc | Houston | Texas | 77098 | United States |
| Westex Clinical Investigations | Lubbock | Texas | 79423 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | 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 (participants who signed informed consent for whom a randomization number had been assigned) who had taken 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 SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) 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 |
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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-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) 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 (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms. | Full-analysis set (FAS) consisted of the safety set who had at least 1 post-dose ADHD-RS-IV total score assessment. FAS with number of participants evaluable for this outcome. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Visit 6 (Week 4) |
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| Secondary | Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4) | CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). | FAS with number of participants evaluable for this outcome. | Posted | Mean | Standard Deviation | Units on a scale | Visit 6 (Week 4) |
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From start of study drug administration up to safety follow-up assessment (35 days)
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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 | Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks. | 0 | 131 | 26 | 131 | ||
| EG001 | SHP465 | Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during dose maintenance phase) orally once daily for 4 weeks. | 0 | 132 | 67 | 132 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Irritability | Psychiatric 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 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Change at Visit 6 (Week 4) |
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