免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis
Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis
Study Description
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).
| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Sclerosis | Other: Multiple Sclerosis Performance Test (MSPT) |
Study Design
| 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 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- Percentage of Participants Completing All Modules [ Time Frame: Baseline to Month 24 ]
- Percentage of Participants Completing Each Individual Module [ Time Frame: Baseline to Month 24 ]
- Percentage of Participants Skipping Modules [ Time Frame: Baseline to Month 24 ]
- Average Time to Complete the Multiple Sclerosis Performance Test (MSPT) [ Time Frame: Baseline to Month 24 ]
- Average Time to Complete Individual MSPT Modules [ Time Frame: Baseline to Month 24 ]
- Frequency of Reasons for Not Completing MSPT Modules [ Time Frame: Baseline to Month 24 ]
- Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules [ Time Frame: Baseline to Month 24 ]
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Key Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations
- Diagnosis of MS, including Clinically Isolated Syndrome
- Ability to understand the audio and visual instructions for the test modules
- Visual function, based on the investigator's clinical judgement that does not preclude an ability to interact with the Multiple Sclerosis Performance Test (MSPT).
Key Exclusion Criteria:
- Unable or unwilling to provide informed consent
- Participants younger than 18 years of age, unless their parent or legal guardian provides the required signed and dated informed consent and authorization to use confidential health information and the participant provides assent in accordance with national and local subject privacy regulations
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Contacts
| Contact: US Biogen Clinical Trial Center | 866-633-4636 | clinicaltrials@biogen.com | |
| Contact: Global Biogen Clinical Trial Center | clinicaltrials@biogen.com |
Locations
| 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 | |
Sponsors and Collaborators
Biogen
Investigators
| 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 | ||||||||
