Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group

What Was Tested

The paper reports a study of Glatiramer Acetate in the context of multiple sclerosis, published as a randomized controlled trial.

The primary end point was a difference in the MS relapse rate.

Trends in the proportion of relapse-free patients and median time to first relapse favored copolymer 1.

Who Took Part

The abstract describes 13 patients taking part.

By PubMed's age tags, the people studied were adults, both men and women.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and multicenter.

The patients were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

Blinding on both sides kept the patients and researchers unaware of who received Glatiramer Acetate.

Some patients received a placebo instead of Glatiramer Acetate, giving a reference point.

Running at several centres spread the Glatiramer Acetate study over different clinics and patient groups.

Disability was measured by the Expanded Disability Status Scale (EDSS), using a two-neurologist (examining and treating) protocol.

What Was Measured

The primary end point was a difference in the MS relapse rate.

The subject headings attached to it are Disability Evaluation, Drugs, Investigational, Glatiramer Acetate, Multiple Sclerosis, Peptides and Recurrence.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Glatiramer Acetate in 13 patients in people with multiple sclerosis.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 1995 (Neurology), a journal based in United States.

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