Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome

What Was Tested

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

The secondary objective is to assess, within the time frame of the up to 3-year double-blind, placebo-controlled study period, the effect of GA on clinical and Magnetic Resonance Imaging (MRI) parameters.

The long-term objectives of the study (exploratory in nature) are to assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed treatment with GA as reflected by clinical and MRI parameters measuring the accumulated irreversible brain tissue damage.

It had two arms (groups): Glatiramer acetate (experimental) and Placebo (DB) to GA (OL) (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

481 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: The subject must have undergone a single clinical attack. The subject must have a unifocal clinical presentation. The subject should be enrolled within the period of 90 days after onset of a single unifocal clinical attack (index attack). There must be 2 or more cerebral lesions highly suspicious of multiple sclerosis (MS) on the screening Magnetic Resonance Imaging (MRI), measuring 6mm or more in diameter. Subjects must be between the ages of 18 and 45 years inclusive.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: multifocal clinical presentation; use of experimental or investigational drugs, including iv immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry; use of interferon agents within 6 months prior to the screening visit.

How the Study Was Run

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

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

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

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, care provider, investigator and outcomes assessor.

It started in 2004-01 with completion listed for 2007-10.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion (time frame: up to 3 years).

It also tracked 4 secondary outcomes, for example Number of New T2 Brain Lesions Observed at the Last Observed Value (LOV) in the Double-blind Period, Change From Baseline to Last Observed Value (LOV) in T2 Brain Lesion Volume in the Double-blind Period and Percentage of Participants Who Converted to Clinically Definite Multiple Sclerosis (CDMS) During the Double-blind Period.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 481 people with multiple sclerosis.

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.