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The purpose of this study is to evaluate the utility of the S-STREAM as an instrument to assess motor function in subjects who have experienced a nonhemorrhagic ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonhemorrhagic Ischemic Stroke | Subjects obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | This was an observational study and no study drug was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM fit the requirements of the Rasch model. The raw scores were Rasch transformed to achieve logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean change from baseline in S-STREAM Rasch-transformed score is being reported; higher S-STREAM scores indicate better outcomes. | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| Mean Percent Change From Baseline in Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM has been shown to fit the requirements of the Rasch model. The raw scores were Rasch transformed to get the logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean percent change from baseline in S-STREAM Rasch transformed score is being reported; higher S-STREAM scores indicate better outcomes. | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| Number of Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke With Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score, by Category |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup Analysis of Total S-STREAM Score and Mean Change From Baseline to Day 84 in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM has been shown to fit the requirements of the Rasch model. The raw scores were Rasch transformed to get the logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean change from baseline in S-STREAM Rasch-transformed score is being reported; higher S-STREAM scores indicate better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants may be selected upon admission to an acute care emergency center, inpatient facility, or rehabilitation center.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | 92658 | United States | |||
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
All participants received standard of care based on investigator opinion and institutional policy.
A total of 120 participants who met all inclusion and no exclusion criteria were enrolled in the study at 36 sites (30 sites in the United States and 6 sites in Canada).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). The S-STREAM assessments are conducted in the order of the following positions: supine, sitting, and standing. Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). Based on the point scales described, the maximum score for upper limb movements is 10, for lower limb movements is 10, and for mobility is 15; the maximum aggregate S-STREAM raw score is therefore 35. Higher S-STREAM scores indicated better outcome. Total S-STREAM scores were generated using Rasch transformations and subsequently scaled to scores between 0 and 100 for purposes of analysis with higher total S-STREAM scores indicating a better outcome. |
| Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| Mean Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The NIHSS is a stroke deficit assessment scale composed of 11 components, where a score of 0 is defined as normal while higher scores indicate increasing severity of impairment for each component. Components include level of consciousness (3 evaluations, 2 of which are scored 0 to 2 and 1 of which is scored 0 to 3), best gaze (scored 0 to 2), visual (scored 0 to 3), facial palsy (scored 0 to 3), motor arm (scored 0 to 4 in both arms), motor leg (scored 0 to 4 in both legs), limb ataxia (scored 0 to 2), sensory (scored 0 to 2), best language (scored 0 to 3), dysarthria (scored 0 to 2), and extinction and inattention (scored 0 to 2). The total NIHSS score is calculated by summing individual scores. The maximum total score on the NIHSS is 42 and the level of stroke severity ranges from 0 (normal, no stroke) to 42 (severe stroke). Higher NIHSS scores indicate worse outcome. The mean change from baseline is also being reported; the greater the negative value, the better the outcome. | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| Mean Percent Change From Baseline in National Institutes of Health Stroke Scale Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The NIHSS is a stroke deficit assessment scale composed of 11 components, where a score of 0 is defined as normal while higher scores indicate increasing severity of impairment for each component. Components include level of consciousness (3 evaluations, 2 of which are scored 0 to 2 and 1 of which is scored 0 to 3), best gaze (scored 0 to 2), visual (scored 0 to 3), facial palsy (scored 0 to 3), motor arm (scored 0 to 4 in both arms), motor leg (scored 0 to 4 in both legs), limb ataxia (scored 0 to 2), sensory (scored 0 to 2), best language (scored 0 to 3), dysarthria (scored 0 to 2), and extinction and inattention (scored 0 to 2). The total NIHSS score is calculated by summing individual component scores. The max total score on NIHSS is 42 and the level of stroke severity as measured by the overall NIHSS score ranges from 0 (normal, no stroke) to 42 (severe stroke). The mean percent change from baseline is being reported; the greater the negative value, the better the outcome. | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Lawrenceville | Georgia | 30045 | United States |
| Chicago | Illinois | 60612 | United States |
| Des Moines | Iowa | 50314 | United States |
| Boston | Massachusetts | 02114 | United States |
| Springfield | Massachusetts | 01199 | United States |
| Worcester | Massachusetts | 01606 | United States |
| Detroit | Michigan | 48236 | United States |
| Edison | New Jersey | 08818 | United States |
| Brooklyn | New York | 11220 | United States |
| The Bronx | New York | 10467 | United States |
| Portland | Oregon | 97239 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Charleston | South Carolina | 29402 | United States |
| Chattanooga | Tennessee | 37403 | United States |
| Nashville | Tennessee | 37232-2551 | United States |
| Norfolk | Virginia | 23507 | United States |
| Richmond | Virginia | 23298 | United States |
| Seattle | Washington | 98104 | United States |
| Calgary | Alberta | T2N 2T9 | Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Edmonton | Alberta | T6L 5X8 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were assessed in the Primary Analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Mean Change From Baseline in Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM fit the requirements of the Rasch model. The raw scores were Rasch transformed to achieve logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean change from baseline in S-STREAM Rasch-transformed score is being reported; higher S-STREAM scores indicate better outcomes. | Total Simplified-Stroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in the Primary Analysis population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
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| Primary | Mean Percent Change From Baseline in Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM has been shown to fit the requirements of the Rasch model. The raw scores were Rasch transformed to get the logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean percent change from baseline in S-STREAM Rasch transformed score is being reported; higher S-STREAM scores indicate better outcomes. | Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in the Primary Analysis population. | Posted | Mean | Standard Deviation | percent change | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| |||||||||||||||||||||||||||||
| Primary | Number of Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke With Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score, by Category | The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). The S-STREAM assessments are conducted in the order of the following positions: supine, sitting, and standing. Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). Based on the point scales described, the maximum score for upper limb movements is 10, for lower limb movements is 10, and for mobility is 15; the maximum aggregate S-STREAM raw score is therefore 35. Higher S-STREAM scores indicated better outcome. Total S-STREAM scores were generated using Rasch transformations and subsequently scaled to scores between 0 and 100 for purposes of analysis with higher total S-STREAM scores indicating a better outcome. | Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in the Primary Analysis population. | Posted | Count of Participants | Participants | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
| ||||||||||||||||||||||||||||||
| Secondary | Subgroup Analysis of Total S-STREAM Score and Mean Change From Baseline to Day 84 in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM has been shown to fit the requirements of the Rasch model. The raw scores were Rasch transformed to get the logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean change from baseline in S-STREAM Rasch-transformed score is being reported; higher S-STREAM scores indicate better outcomes. | Subgroup analysis of Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in patients with available data in the Primary Analysis population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
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| Secondary | Mean Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The NIHSS is a stroke deficit assessment scale composed of 11 components, where a score of 0 is defined as normal while higher scores indicate increasing severity of impairment for each component. Components include level of consciousness (3 evaluations, 2 of which are scored 0 to 2 and 1 of which is scored 0 to 3), best gaze (scored 0 to 2), visual (scored 0 to 3), facial palsy (scored 0 to 3), motor arm (scored 0 to 4 in both arms), motor leg (scored 0 to 4 in both legs), limb ataxia (scored 0 to 2), sensory (scored 0 to 2), best language (scored 0 to 3), dysarthria (scored 0 to 2), and extinction and inattention (scored 0 to 2). The total NIHSS score is calculated by summing individual scores. The maximum total score on the NIHSS is 42 and the level of stroke severity ranges from 0 (normal, no stroke) to 42 (severe stroke). Higher NIHSS scores indicate worse outcome. The mean change from baseline is also being reported; the greater the negative value, the better the outcome. | National Institutes of Health Stroke Scale (NIHSS) Score was assessed in the Primary Analysis population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
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| Secondary | Mean Percent Change From Baseline in National Institutes of Health Stroke Scale Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke | The NIHSS is a stroke deficit assessment scale composed of 11 components, where a score of 0 is defined as normal while higher scores indicate increasing severity of impairment for each component. Components include level of consciousness (3 evaluations, 2 of which are scored 0 to 2 and 1 of which is scored 0 to 3), best gaze (scored 0 to 2), visual (scored 0 to 3), facial palsy (scored 0 to 3), motor arm (scored 0 to 4 in both arms), motor leg (scored 0 to 4 in both legs), limb ataxia (scored 0 to 2), sensory (scored 0 to 2), best language (scored 0 to 3), dysarthria (scored 0 to 2), and extinction and inattention (scored 0 to 2). The total NIHSS score is calculated by summing individual component scores. The max total score on NIHSS is 42 and the level of stroke severity as measured by the overall NIHSS score ranges from 0 (normal, no stroke) to 42 (severe stroke). The mean percent change from baseline is being reported; the greater the negative value, the better the outcome. | National Institutes of Health Stroke Scale (NIHSS) Score was assessed in the Primary Analysis population. | Posted | Mean | Standard Deviation | percent change | Baseline up to Day 84 post non-hemorrhagic ischemic stroke |
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All-cause mortality was assessed from baseline up to Day 84 post non-hemorrhagic ischemic stroke.
This was an observational study and no study drug was administered; therefore, safety events were not assessed in this study.
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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 | All Participants | Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke. | 1 | 120 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Day 7 |
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| Day 28 |
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| Day 56 |
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| Day 84 |
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