Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine

What Was Tested

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

This study evaluates the effect of the therapy combining GA and NAC on disease activity as reflected by MRI parameters while assessing tolerability and safety.

It had 1 arm (groups): Glatiramer Acetate, N-Acetylcysteine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 18 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 Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983). Subjects must have at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans. Subjects must have a relapsing-remitting disease course. Subjects must have had at least one documented relapse within the last year prior to the screening visit (week -10). Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: previous use of injected glatiramer acetate; previous use of cladribine within 2 years prior to screening visit (week -10); previous use of immunosuppressive agents in the last 6 months.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-12 with completion listed for 2006-08.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in the sum of T1 Gd-enhancing lesions as reflected by MRI (time frame: 46 weeks).

It also tracked 1 secondary outcome, for example MRI parameters.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Glatiramer Acetate in 18 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

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.