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NCT03926637 Clinical Trial

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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03926637
Other study ID # US-MSG-18-11424
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 17, 2019
Est. completion date December 5, 2022

Study information
Verified date January 2023
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 3073
Est. completion date December 5, 2022
Est. primary completion date December 5, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Multiple Sclerosis Performance Test (MSPT)
Administered as specified in the treatment arm.

Locations
Country Name City State
Czechia Research Site Prague
France Research Site Strasbourg
Italy Research Site Bari
Italy Research Site Catania
Italy Research Site Milano
Italy Research Site Orbassano
Italy Research Site Roma
Switzerland Research Site Basel
Switzerland Research Site Bern
United Kingdom Research Site Camberley
United Kingdom Research Site Oxford
United States Research Site Atlanta Georgia
United States Research Site Atlanta Georgia
United States Research Site Aurora Colorado
United States Research Site Berkeley California
United States Research Site Boston Massachusetts
United States Research Site Buffalo New York
United States Research Site Chicago Illinois
United States Research Site Dallas Texas
United States Research Site Durham North Carolina
United States Research Site Farmington Hills Michigan
United States Research Site Los Angeles California
United States Research Site Oklahoma City Oklahoma
United States Research Site Owosso Michigan
United States Research Site Philadelphia Pennsylvania
United States Research Site Pittsburgh Pennsylvania
United States Research Site Portland Oregon
United States Research Site Saint Louis Missouri
United States Research Site Salt Lake City Utah
United States Research Site Seattle Washington
United States Research Site Spokane Washington
United States Research Site Teaneck New Jersey
United States Research Site Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Czechia,  France,  Italy,  Switzerland,  United Kingdom, 

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