A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

What Was Tested

This registered phase 2 trial tested Glatiramer Acetate for multiple sclerosis.

It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.

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 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: Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course. 2.EDSS 0.0 - 6.5 inclusive. 18 to 55 years of age. 1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions. Able and willing to sign and date an informed consent form.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: patients ever treated with glatiramer acetate or mitoxantrone; patients treated with interferons or iv immunoglobulins (iv ig) in the previous 4 weeks prior to screening visits; patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2003-06 with completion listed for 2005-01.

Its stated primary purpose is diagnostic.

What This Means in Plain Language

Put simply, this is a phase 2, 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.