Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline

What Was Tested

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

This study investigates the add-on effect of oral minocycline in subjects treated with daily injection of Copaxone.

Copaxone and minocycline are thought to have differential modes of actions that may complement each other in treating MS symptoms.

It had two arms (groups): Glatiramer Acetate injection with oral minocycline (active comparator) and Glatiramer Acetate with placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 44 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 as defined by Poser et al. (Ann. Neurol. 1983) with disease duration (from onset) of at least 6 months. Subjects must have a relapsing-remitting disease course. 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.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: previous use of injectable glatiramer acetate; previous use of cladribine; previous use of immunosuppressive agents in the last 6 months.

How the Study Was Run

Design: 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.

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

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 2004-06 with completion listed for 2006-06.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To evaluate the add-on treatment effect of oral minocycline in subjects treated with daily injection of GA as reflected by number of MRI T1 Gd-enhancing lesions in T1-weighted images (time frame: 24 months).

It also tracked 1 secondary outcome, for example Assessment of tolerability and safety.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 44 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.