Multiple Sclerosis
Conditions
Keywords
Clinically Isolated Syndrome
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).
Interventions
Administered as specified in the treatment arm.
Sponsors
Study design
Eligibility
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Completing All Modules | Baseline to Month 24 |
| Percentage of Participants Completing Each Individual Module | Baseline to Month 24 |
| Percentage of Participants Skipping Modules | Baseline to Month 24 |
| Average Time to Complete the Multiple Sclerosis Performance Test (MSPT) | Baseline to Month 24 |
| Average Time to Complete Individual MSPT Modules | Baseline to Month 24 |
| Frequency of Reasons for Not Completing MSPT Modules | Baseline to Month 24 |
| Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules | Baseline to Month 24 |
Countries
Czechia, France, Italy, Switzerland, United Kingdom, United States