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Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926637
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

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)

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Percentage of Participants Completing All Modules [ Time Frame: Baseline to Month 24 ]
  2. Percentage of Participants Completing Each Individual Module [ Time Frame: Baseline to Month 24 ]
  3. Percentage of Participants Skipping Modules [ Time Frame: Baseline to Month 24 ]
  4. Average Time to Complete the Multiple Sclerosis Performance Test (MSPT) [ Time Frame: Baseline to Month 24 ]
  5. Average Time to Complete Individual MSPT Modules [ Time Frame: Baseline to Month 24 ]
  6. Frequency of Reasons for Not Completing MSPT Modules [ Time Frame: Baseline to Month 24 ]
  7. Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules [ Time Frame: Baseline to Month 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926637


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
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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
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03926637    
Other Study ID Numbers: US-MSG-18-11424
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: http://www.biogenclinicaldatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
Clinically Isolated Syndrome
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases