Feasibility of the Multiple Sclerosis Performance Tool in MS patients
Research type
Research Study
Full title
Feasibility of the Multiple Sclerosis Performance Test (MSPT) tool for assessment of functional performance measures in Multiple Sclerosis (MS) patients
IRAS ID
243039
Contact name
Matthew Craner
Contact email
Sponsor organisation
Biogen Idec Research Limited, UK
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT03926637, NCT Number
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Multiple Sclerosis (MS) is a chronic autoimmune disease of the central nervous system (CNS) causing neurological disability. The routine measurement of neurological and neuropsychological impairment and disability remains challenging, largely due to the time constraints placed on medical professionals.
The MS Performance Test (MSPT) assessment tool has been developed via collaboration between Biogen and the Cleveland Clinic Mellen Centre and is designed to measure the major motor, visual and cognitive function data, and quality of life outcomes, associated with MS and related disorders. These assessment modules of the MSPT are self-administered by MS patients at the point of care.
This observational study sponsored by Biogen will examine the use of the Multiple Sclerosis Performance Tool (MSPT) in a real world setting. Approximately 6,400 participants will be recruited from 20 centres in the United States, 5 centres in Italy, 5 centres in France, and 2 centres in the UK.
The study period will consist of screening and self-administration of the MSPT during routine clinic visits over a follow-up of up to 24 months. The end of study will occur when the last study participant has their final routine visit, defined as a routinely scheduled visit in the 18-24 months period after their baseline MSPT assessment.
The data collected at enrolment will coincide with a routine clinical visit to the Investigator. Subsequent data will also be collected during routine clinical visits for up to 2 years from enrolment. Visits are anticipated to occur every 6-8 months, but may vary according to the site's standard of care.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0017
Date of REC Opinion
12 Mar 2020
REC opinion
Further Information Favourable Opinion