Comparison of the EDSS, Timed 25-Foot Walk, and the 9-Hole Peg Test as Clinical Trial Outcomes in Relapsing-Remitting Multiple Sclerosis

What Was Tested

This randomized controlled trial paper looks at Glatiramer Acetate in the context of multiple sclerosis.

Clinical trials in relapsing-remitting multiple sclerosis (RRMS) usually use the Expanded Disability Status Scale (EDSS) as their primary disability outcome measure, while the more recently developed outcomes timed 25-ft walk (T25FW) and 9-hole peg test (NHPT) may be more useful and patient relevant.

The objective of this work was to compare the EDSS to the T25FW and NHPT in a large RRMS randomized controlled trial (RCT) dataset.

The researchers used the dataset from Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) (clinicaltrials.gov identifier NCT00211887), a large phase 3 RCT, to compare the EDSS to the alternative outcomes T25FW and NHPT.

Who Took Part

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

How the Study Was Run

In design terms this was a randomized and double-blind study.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

What Was Measured

PubMed files the paper under topics including Disability Evaluation, Glatiramer Acetate, Interferon-beta and Multiple Sclerosis, Relapsing-Remitting.

What This Means in Plain Language

The paper is a randomized and double-blind study of Glatiramer Acetate in people with multiple sclerosis.

Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2021 (Neurology), a journal based in United States.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.