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

January 27, 2023 updated by: Biogen

Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3073

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 12000
        • Research Site
  • France
      • Strasbourg, France, 67200
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Catania, Italy, 95123
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Orbassano, Italy, 10043
        • Research Site
      • Roma, Italy, 00185
        • Research Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Research Site
      • Bern, Switzerland, 3010
        • Research Site
  • United Kingdom
      • Camberley, United Kingdom, GU16 7UJ
        • Research Site
      • Oxford, United Kingdom, OX3 9DU
        • Research Site
  • United States
    • California
      • Berkeley, California, United States, 94705
        • Research Site
      • Los Angeles, California, United States, 90033-5310
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Atlanta, Georgia, United States, 30327
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60008
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
      • Owosso, Michigan, United States, 48867
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Research Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Research Site
    • New York
      • Buffalo, New York, United States, 14202
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75390-8806
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98122
        • Research Site
      • Spokane, Washington, United States, 99208
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Completing All Modules
Time Frame: Baseline to Month 24
Baseline to Month 24
Percentage of Participants Completing Each Individual Module
Time Frame: Baseline to Month 24
Baseline to Month 24
Percentage of Participants Skipping Modules
Time Frame: Baseline to Month 24
Baseline to Month 24
Average Time to Complete the Multiple Sclerosis Performance Test (MSPT)
Time Frame: Baseline to Month 24
Baseline to Month 24
Average Time to Complete Individual MSPT Modules
Time Frame: Baseline to Month 24
Baseline to Month 24
Frequency of Reasons for Not Completing MSPT Modules
Time Frame: Baseline to Month 24
Baseline to Month 24
Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules
Time Frame: Baseline to Month 24
Baseline to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

April 22, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-MSG-18-11424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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