Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).

What Was Tested

The trial (phase 3) is built around Glatiramer Acetate for multiple sclerosis.

GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1155 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: Diagnosis of confirmed and documented MS defined by the Revised McDonald criteria. Subjects must be of the relapsing-remitting (R-R) type. Disease duration for at least 6 months. Ambulatory with converted Kurtzke EDSS score of 0 - 5. Relapse free and stable neurological condition at least for 30 days prior screening.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: previous use of copaxone (glatiramer acetate); treatment with corticosteroids within 30 days prior screening or between screening and baseline; chronic corticosteroids treatment - more than 30 consecutive days.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2006-08 with completion listed for 2008-10.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Rate of Confirmed Relapses During the Double-blind Phase (12 Months) (time frame: 12 months).

It also tracked 2 secondary outcomes, for example The Number of New T2 Lesions at Month 12 as Compared to the Baseline Scan and The Cumulative Number of T1-Gd Enhancing Lesions at Months 3, 6, 9 and 12 (in the Frequent MRI Cohort-described Below).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 1155 people with multiple sclerosis.

With 1155 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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