Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis

What Was Tested

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

BG-12 (dimethyl fumarate) is in development as an oral treatment for relapsing-remitting multiple sclerosis, which is commonly treated with parenteral agents (interferon or glatiramer acetate).

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, double-blind and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

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

A placebo (an inactive look-alike) gave the Glatiramer Acetate group a baseline to be compared against.

A time span of 2 years appears in the methods.

An active agent, glatiramer acetate, was also included as a reference comparator.

The primary end point was the annualized relapse rate over a period of 2 years.

What Was Measured

PubMed files the paper under topics including Brain, Dimethyl Fumarate, Fumarates, Glatiramer Acetate, Immunosuppressive Agents, Infections and Intention to Treat Analysis.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Glatiramer Acetate in people with multiple sclerosis over 2 years.

The abstract goes on to report its results in about 9 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2012 (The New England journal of medicine), a journal based in United States.

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