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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003313-34 | EudraCT Number |
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To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine dimesylate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine dimesylate | Drug | 50 or 70 mg administered orally, once a day for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety | 52 weeks | |
| Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "no," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide. | 53 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | The CGI rating scales permitted the global evaluation of a participant's condition severity and improvement over time. The CGI-I was 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) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation. |
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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 |
|---|---|---|---|---|---|---|
| Birmingham Research Group | Birmingham | Alabama | 35216 | United States | ||
| Radiant Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28383364 | Result | Gasior M, Hudson J, Quintero J, Ferreira-Cornwell MC, Radewonuk J, McElroy SL. A Phase 3, Multicenter, Open-Label, 12-Month Extension Safety and Tolerability Trial of Lisdexamfetamine Dimesylate in Adults With Binge Eating Disorder. J Clin Psychopharmacol. 2017 Jun;37(3):315-322. doi: 10.1097/JCP.0000000000000702. |
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This was an open-label extension study to evaluate the long-term safety of SPD489 in adults aged 18-55 years with binge eating disorder (BED) who completed 1 of 3 antecedent studies, all of which tested SPD489 for BED (SPD489-208, SPD489-343, or SPD489-344).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) |
| Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) | The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline. | Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) |
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Clinical Study Centers, LLC | Little Rock | Arkansas | 72211 | United States |
| Southwestern Research, Inc. | Beverly Hills | California | 90210 | United States |
| TRIMED Clinical Trials | Corona | California | 92880 | United States |
| Pharmacology Research Institute | Encino | California | 91316 | United States |
| Scripps Clinical Research Services | La Jolla | California | 92037 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Pacific Research Partners, LLC | Oakland | California | 94612 | United States |
| Excell Research, Inc | Oceanside | California | 92056 | United States |
| PCSD - Feighner Research | San Diego | California | 92108 | United States |
| Western Affiliated Research Institute, Inc | Denver | Colorado | 80209 | United States |
| Radiant Research, Inc | Denver | Colorado | 80239 | United States |
| Florida Clinical Research | Bradenton | Florida | 34201 | United States |
| Gulfcoast Clinical Research | Fort Myers | Florida | 33912 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32216 | United States |
| Fidelity Clinical Research, Inc | Lauderhill | Florida | 33319 | United States |
| Compass Research, LLC | Leesburg | Florida | 34748 | United States |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | United States |
| Scientific Clinical Research, Inc | North Miami | Florida | 33161 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32806 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Atlanta Institute of Medicine and Research | Atlanta | Georgia | 30328 | United States |
| Neurotrials Research, Inc | Atlanta | Georgia | 30342 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Baber Research Group | Naperville | Illinois | 60563 | United States |
| American Medical Research, Inc | Oak Brook | Illinois | 60523 | United States |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46260 | United States |
| Deaconess Health Center | Newburgh | Indiana | 47630 | United States |
| Clinical Trials Technology, Inc | Prairie Village | Kansas | 66206 | United States |
| Cypress Medical Research Center, LLC | Wichita | Kansas | 67226 | United States |
| Louisana Research Associates, Inc | New Orleans | Louisiana | 70114 | United States |
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Activmed Practices & Research | Methuen | Massachusetts | 01844 | United States |
| Adams Clinical Trials, LLC | Watertown | Massachusetts | 02472 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| St. Charles Psychiatric Associates-Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Robert Lynne Horne, MD | Las Vegas | Nevada | 89102 | United States |
| Center for Psychiatry & Behavioral Medicine, Inc | Las Vegas | Nevada | 89128 | United States |
| Global Medical Institues, LLC | Princeton | New Jersey | 08540 | United States |
| Pacific Institute for Research & Evaluation | Albuquerque | New Mexico | 87102 | United States |
| Brooklyn Medical Institute | Brooklyn | New York | 11214 | United States |
| Comprehensive Clinical Development | Jamaica | New York | 11432 | United States |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | United States |
| CNS Clinica | New York | New York | 10023 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Radiant Research, Inc | Akron | Ohio | 44311 | United States |
| Patient Priority Clinical Sites | Cincinnati | Ohio | 45215 | United States |
| Community Research | Cincinnati | Ohio | 45227 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Lindner Center of Hope | Mason | Ohio | 45040 | United States |
| North Star Medical Research, LLC | Middleburg Heights | Ohio | 44130 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Oregon Psychiatric Partners, Llp | Eugene | Oregon | 97401 | United States |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | United States |
| Oregon Center for Clinical Research, Inc | Portland | Oregon | 97210 | United States |
| Oregon Center for Clinical Investigations, Inc | Salem | Oregon | 97301 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| The Clinical Trial Center, LLC. | Jenkintown | Pennsylvania | 19046 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | 15206 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Radiant Research, Inc | Anderson | South Carolina | 29621 | United States |
| Radiant Research, Inc | Greer | South Carolina | 29650 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Neuroscience Solutions, Inc (CNS Healthcare) | Memphis | Tennessee | 38119 | United States |
| Clinical Research Associates, Inc | Nashville | Tennessee | 37203 | United States |
| Futuresearch Clinical Trials | Austin | Texas | 78731 | United States |
| Futuresearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Texas Center for Drug Development, Inc | Houston | Texas | 77081 | United States |
| Psychiatric Medical Associates | Plano | Texas | 75093 | United States |
| Radiant Research, Inc | San Antonio | Texas | 78229 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Radiant Research, Inc | Murray | Utah | 84123 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Neuropsychiatric Associates | Woodstock | Vermont | 05091 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Neuroscience, Inc | Herndon | Virginia | 20170 | United States |
| Northwest Clinical Research | Bellevue | Washington | 98007 | United States |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98104 | United States |
| Dean Foundation | Middleton | Wisconsin | 53562 | United States |
| Klinische Forschung Berlin-Mitte GmbH | Berlin | 10117 | Germany |
| Ernovis GmbH | Berlin | 10629 | Germany |
| Klinische Forschung Dresden GmbH | Dresden | 1069 | Germany |
| Klinische Forschung Hannover-Mitte | Hanover | 30159 | Germany |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week. |
| 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 |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety | The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | percentage of participants | 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "no," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide. | The Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | participants | 53 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | The CGI rating scales permitted the global evaluation of a participant's condition severity and improvement over time. The CGI-I was 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) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation. | The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) | The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline. | The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | percentage of participants at ET | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | percentage of participants at ET | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | percentage of participants at ET | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | percentage of participants at ET | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression | The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit. | The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study. | Posted | Number | percentage of participants at ET | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) |
|
Not provided
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week. | 17 | 599 | 447 | 599 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Adjustment disorder with anxiety | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bruxism | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
|
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 |
|---|---|
| D056912 | Binge-Eating Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
|
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| Participants |
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| Participants |
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