Treatment of Multiple Sclerosis With Copaxone and Albuterol

What Was Tested

The trial (not phased) is built around Glatiramer Acetate for multiple sclerosis.

The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS).

MS is thought to be an autoimmune disease of the central nervous system.

Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers.

It had two arms (groups): 1 (experimental) and 2 (experimental).

Participants will receive Copaxone and albuterol placebo.

Participants will receive Copaxone and albuterol.

The registry classes the interventions as drug.

More on the Plan

MS is a chronic inflammatory disease of the central nervous system characterized by focal T cell and macrophage infiltrates that lead to demyelination and loss of neurologic function.

Three of these are approved for the treatment of patients with the relapsing-remitting (RR) form of MS, in which patients have clinical exacerbations followed by partial or complete recovery of function.

Thus, there is a need to find therapies with low toxicities that can be administered early during the disease course with the potential for arresting the disease.

During the pre-treatment phase, patients undergo neurological exams, including the extended disability status scale (EDSS), Ambulation Index (AI), disease steps (DS) scale MS functional composite score, PASAT, 9 hole peg test, and the 25 foot walking time.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have been diagnosed with RR-MS, within 2 years of diagnosis. Are 18-55 years old. Have RR-MS with evidence of demyelination on MRI scanning of the brain. Have extended disability status scale (EDSS) scores between 0 and 3.5. Have not taken Copaxone or oral myelin.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: have a normal brain mri; are not willing to practice contraception (applies to women who are able to have children); are pregnant or breast-feeding.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and care provider.

It started in 2001-11 with completion listed for 2006-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (time frame: Throughout study). Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (time frame: At Months 3, 6, and 12).

It also tracked 6 secondary outcomes, for example Change in IL-5 secretion in the supernatants of lines stimulated with glatiramer acetate, Change in percentage of IL-12-producing monocytes by intracytoplasmic staining, Time to first exacerbation, Number and severity of exacerbations and Expanded Disability Status Scale (EDSS), Ambulation Index (AI), and Disease Steps (DS) scores.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glatiramer Acetate in 40 people with multiple sclerosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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