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Lesion remyelinating activity of GSK239512 versus placebo in patients with relapsing-remitting multiple sclerosis: a randomised, single-blind, phase II study

Plain-language guide to PMID 27888416 (2017): double-blind randomized controlled trial study of Glatiramer Acetate in 131 patients, multiple sclerosis.

Key Facts

PMID
27888416
Journal
Journal of neurology
Year
2017
Study type
Randomized Controlled Trial
Authors
Schwartzbach CJ et al. (6 authors)
DOI
10.1007/s00415-016-8341-7

What This Study Did, in Plain Language

What Was Tested

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

Histamine H3 receptor blockade may enhance lesion remyelination in multiple sclerosis (MS).

The co-primary endpoints were mean changes in post-lesion MTR in gadolinium-enhanced (GdE) or Delta-MTR defined lesions from pre-lesion values.

Who Took Part

The study group was 131 patients.

PubMed indexes the participants as young adults, adults and middle-aged adults, both men and women.

How the Study Was Run

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

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

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

Only one side, usually the patients, was kept unaware of whether Glatiramer Acetate was given.

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

What Was Measured

The co-primary endpoints were mean changes in post-lesion MTR in gadolinium-enhanced (GdE) or Delta-MTR defined lesions from pre-lesion values.

PubMed files the paper under topics including Adjuvants, Immunologic, Benzazepines, Brain, Glatiramer Acetate, Gray Matter, Histamine Antagonists and Interferon beta-1a.

The authors tagged it with the keywords GSK239512, Magnetic resonance imaging, Magnetisation transfer ratio, Relapsing-remitting multiple sclerosis and Remyelination.

What This Means in Plain Language

The paper is a randomized, double-blind and single-blind study of Glatiramer Acetate in 131 patients in people with multiple sclerosis.

The publication is from 2017 (Journal of neurology), a journal based in Germany.

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

Our Notes on the Compound

Glatiramer Acetate: A mix of synthetic amino-acid chains (Copaxone) used in relapsing multiple sclerosis.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.