A Study to Test the Effectiveness and Safety of a New Higher [amount hidden] Dose of Copaxone® Compared to Copaxone® [amount hidden], the Currently Approved Dose

What Was Tested

In this phase 2 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Clinically definite MS with disease duration (from onset) of at least 6 months. Subjects must have had at least 1 documented relapse within the last year prior to study entry. Subjects must have at least 1 and not more than 15 gadolinium (Gd)-enhancing lesions on the screening MRI scan. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit. Subjects must not have taken corticosteroids (IV, IM and/or PO) between the screening and baseline visits.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: previous use of glatiramer acetate (oral or injectable); previous use of cladribine; previous use of immunosuppressive agents in the last 6 months.

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.

Neither the multiple sclerosis participants nor the staff measuring them knew who was on Glatiramer Acetate, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2003-08 with completion listed for 2005-09.

It ran at 20 sites in United States (20).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The total number of T1 Gd-enhancing lesions in T1-weighted images, as measured at months 7, 8 and 9.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 90 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.