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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
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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
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 :
  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 ]

Eligibility Criteria
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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.

Contacts and Locations

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
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
 (submitted: April 22, 2019)
  • 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 ]
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
 (submitted: April 22, 2019)
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:

  • 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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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: https://vivli.org/
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date March 2021