Condition or disease | Intervention/treatment |
---|---|
Multiple Sclerosis | Other: Multiple Sclerosis Performance Test (MSPT) |
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis |
Actual Study Start Date : | June 17, 2019 |
Estimated Primary Completion Date : | September 1, 2022 |
Estimated Study Completion Date : | February 1, 2023 |
Group/Cohort | Intervention/treatment |
---|---|
Study Participants
Participants with MS, including CIS will complete the MSPT at their standard of care visits.
|
Other: Multiple Sclerosis Performance Test (MSPT)
Administered as specified in the treatment arm.
|
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contact: US Biogen Clinical Trial Center | 866-633-4636 | clinicaltrials@biogen.com | |
Contact: Global Biogen Clinical Trial Center | clinicaltrials@biogen.com |
United States, California | |
Research Site | Not yet recruiting |
Berkeley, California, United States, 94705 | |
Research Site | Not yet recruiting |
Los Angeles, California, United States, 90033-5310 | |
United States, Colorado | |
Research Site | Withdrawn |
Aurora, Colorado, United States, 80045 | |
United States, District of Columbia | |
Research Site | Not yet recruiting |
Washington, District of Columbia, United States, 20007 | |
United States, Georgia | |
Research Site | Recruiting |
Atlanta, Georgia, United States, 30309 | |
Research Site | Recruiting |
Atlanta, Georgia, United States, 30327 | |
United States, Illinois | |
Research Site | Recruiting |
Chicago, Illinois, United States, 60008 | |
United States, Massachusetts | |
Research Site | Recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Research Site | Recruiting |
Farmington Hills, Michigan, United States, 48334 | |
Research Site | Recruiting |
Owosso, Michigan, United States, 48867 | |
United States, Missouri | |
Research Site | Not yet recruiting |
Saint Louis, Missouri, United States, 63131 | |
United States, New Jersey | |
Research Site | Recruiting |
Teaneck, New Jersey, United States, 07666 | |
United States, New York | |
Research Site | Recruiting |
Buffalo, New York, United States, 14202 | |
United States, North Carolina | |
Research Site | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Oklahoma | |
Research Site | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Oregon | |
Research Site | Recruiting |
Portland, Oregon, United States, 97225 | |
United States, Pennsylvania | |
Research Site | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Research Site | Terminated |
Pittsburgh, Pennsylvania, United States, 15212 | |
United States, Texas | |
Research Site | Withdrawn |
Dallas, Texas, United States, 75390-8806 | |
United States, Utah | |
Research Site | Recruiting |
Salt Lake City, Utah, United States, 84103 | |
United States, Washington | |
Research Site | Recruiting |
Seattle, Washington, United States, 98122 | |
Research Site | Recruiting |
Spokane, Washington, United States, 99208 | |
Canada, Alberta | |
Research Site | Withdrawn |
Calgary, Alberta, Canada, T2N 4N1 | |
Research Site | Withdrawn |
Edmonton, Alberta, Canada, T6G 2R3 | |
Canada, British Columbia | |
Research Site | Withdrawn |
Vancouver, British Columbia, Canada, V6T 1Z3 | |
Canada, Ontario | |
Research Site | Withdrawn |
Toronto, Ontario, Canada, M5B1W8 | |
Canada, Quebec | |
Research Site | Withdrawn |
Montreal, Quebec, Canada, H2X 0C1 | |
Czechia | |
Research Site | Recruiting |
Prague, Czechia, 12000 | |
France | |
Research Site | Not yet recruiting |
Amiens Cedex 1, France, 80054 | |
Research Site | Not yet recruiting |
Bron Cedex, France, 69677 | |
Research Site | Not yet recruiting |
Montpellier Cedex 5, France, 34295 | |
Research Site | Not yet recruiting |
Rennes cedex 9, France, 35033 | |
Research Site | Not yet recruiting |
Strasbourg, France, 67200 | |
Italy | |
Research Site | Not yet recruiting |
Bari, Italy, 70124 | |
Research Site | Not yet recruiting |
Catania, Italy, 95123 | |
Research Site | Not yet recruiting |
Milano, Italy, 20132 | |
Research Site | Not yet recruiting |
Orbassano, Italy, 10043 | |
Research Site | Not yet recruiting |
Roma, Italy, 00185 | |
Sweden | |
Research Site | Withdrawn |
Göteborg, Sweden, 41345 | |
Research Site | Withdrawn |
Solna, Sweden, 17177 | |
Switzerland | |
Research Site | Withdrawn |
Basel, Switzerland, 4031 | |
Research Site | Withdrawn |
Bern, Switzerland, 3010 | |
United Kingdom | |
Research Site | Not yet recruiting |
Camberley, United Kingdom, GU16 7UJ | |
Research Site | Not yet recruiting |
Oxford, United Kingdom, OX3 9DU |
Study Director: | Medical Director | Biogen |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date | April 22, 2019 | ||||||||
First Posted Date | April 24, 2019 | ||||||||
Last Update Posted Date | March 24, 2021 | ||||||||
Actual Study Start Date | June 17, 2019 | ||||||||
Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
|
||||||||
Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures | Not Provided | ||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis | ||||||||
Official Title | Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis | ||||||||
Brief Summary | 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). | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||||||
Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | 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. | ||||||||
Condition | Multiple Sclerosis | ||||||||
Intervention | Other: Multiple Sclerosis Performance Test (MSPT)
Administered as specified in the treatment arm.
|
||||||||
Study Groups/Cohorts | Study Participants
Participants with MS, including CIS will complete the MSPT at their standard of care visits.
Intervention: Other: Multiple Sclerosis Performance Test (MSPT)
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
5000 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | February 1, 2023 | ||||||||
Estimated Primary Completion Date | September 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. |
||||||||
Sex/Gender |
|
||||||||
Ages | Child, Adult, Older Adult | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
|
||||||||
Listed Location Countries | Canada, Czechia, France, Italy, Sweden, Switzerland, United Kingdom, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03926637 | ||||||||
Other Study ID Numbers | US-MSG-18-11424 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement |
|
||||||||
Responsible Party | Biogen | ||||||||
Study Sponsor | Biogen | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
|
||||||||
PRS Account | Biogen | ||||||||
Verification Date | March 2021 |