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Biogen will stop any further development of the MSPT. The data collected thus far in the MSPT Feasibility Study allow us to answer the primary study objectives that are associated with assessing the feasibility of the MSPT in a clinical care setting.
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The primary objective is to evaluate the feasibility of the Multiple Sclerosis Performance Test (MSPT) in a clinical care setting when used by participants with Multiple Sclerosis (MS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Participants with MS, including CIS will complete the MSPT at their standard of care visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Sclerosis Performance Test (MSPT) | Other | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Completing All Modules | Baseline to Month 24 | |
| Percentage of Participants Completing Each Individual Module | Baseline to Month 24 | |
| Percentage of Participants Skipping Modules | Baseline to Month 24 | |
| Average Time to Complete the Multiple Sclerosis Performance Test (MSPT) | Baseline to Month 24 | |
| Average Time to Complete Individual MSPT Modules | Baseline to Month 24 | |
| Frequency of Reasons for Not Completing MSPT Modules | Baseline to Month 24 | |
| Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules | Baseline to Month 24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants with a diagnosis of MS, including CIS will be offered study participation during their standard of care clinic visit or by contacting eligible participants identified from medical records.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berkeley | California | 94705 | United States | ||
| Research Site |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Los Angeles |
| California |
| 90033-5310 |
| United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Atlanta | Georgia | 30309 | United States |
| Research Site | Atlanta | Georgia | 30327 | United States |
| Research Site | Chicago | Illinois | 60008 | United States |
| Research Site | Boston | Massachusetts | 02215 | United States |
| Research Site | Farmington Hills | Michigan | 48334 | United States |
| Research Site | Owosso | Michigan | 48867 | United States |
| Research Site | St Louis | Missouri | 63131 | United States |
| Research Site | Teaneck | New Jersey | 07666 | United States |
| Research Site | Buffalo | New York | 14202 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Research Site | Portland | Oregon | 97225 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Dallas | Texas | 75390-8806 | United States |
| Research Site | Salt Lake City | Utah | 84103 | United States |
| Research Site | Seattle | Washington | 98122 | United States |
| Research Site | Spokane | Washington | 99208 | United States |
| Research Site | Prague | 12000 | Czechia |
| Research Site | Strasbourg | 67200 | France |
| Research Site | Bari | 70124 | Italy |
| Research Site | Catania | 95123 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Orbassano | 10043 | Italy |
| Research Site | Roma | 00185 | Italy |
| Research Site | Basel | 4031 | Switzerland |
| Research Site | Bern | 3010 | Switzerland |
| Research Site | Camberley | GU16 7UJ | United Kingdom |
| Research Site | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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