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

Biogen

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Other: Multiple Sclerosis Performance Test (MSPT)

Study type: Observational

Funder types: Industry

Identifiers

NCT03926637

US-MSG-18-11424

Details and patient eligibility

About

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).

Enrollment: 3,073 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

3,073 participants in 1 patient group

Study Participants

Description:

Participants with MS, including CIS will complete the MSPT at their standard of care visits.

Treatment:

Other: Multiple Sclerosis Performance Test (MSPT)