Safety of New Formulation of Glatiramer Acetate

What Was Tested

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

In addition, the investigators will evaluate the side effects of the two formulations of GA.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 147 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Subjects ≥ 18 years of age with a diagnosis of RRMS. Willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study. Willing and able to be trained on a seven site injection rotation. Subject must be willing to comply with a minimum five injection site rotation plan during the study. Willing and able to complete all procedures and evaluations related to the study. Willing to continue to follow usual injection site preparation and routine adjunctive LISR management techniques.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: currently using or treated with another immunomodulating therapy (imt) in conjunction with ga in the 30 days prior to screening for this study; currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study; presence or history of skin necrosis.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

In the crossover set-up each of the multiple sclerosis participants took both Glatiramer Acetate and the comparison in turn, acting as their own control.

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

It started in 2009-07 with completion listed for 2009-09.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Subject-reported Pain Associated Immediately After Each Injection (time frame: 5 weeks of injections).

It also tracked 1 secondary outcome, for example Degree of Pain Within 5 Mins After Injection.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glatiramer Acetate in 147 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.