A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

What Was Tested

This registered phase 4 trial tested Glatiramer Acetate for multiple sclerosis.

This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.

It had two arms (groups): 1 (experimental) and 2 (experimental).

Skin reactions with the use of warm compress prior to performing a Copaxone® injection.

Skin reactions without the use of warm compress prior to performing a Copaxone® injection.

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 50 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: Male or Female, 18 years or older, with a diagnosis of RRMS. Willing and able to complete all procedures and evaluations related to the study. Willing to provide Informed Consent.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: taking any other immunomodulatory therapy in conjunction with copaxone®; any situation which the investigator or nurse feels may interfere with participation in the study; pregnant, or trying to become pregnant, or breast feeding during the study.

How the Study Was Run

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

The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

Each person switched between Glatiramer Acetate and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Glatiramer Acetate study: the multiple sclerosis participants and staff both knew the treatment.

It started in 2005-08 with completion listed for 2005-12.

It ran at 6 sites in United States (6).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The number of local injection site reactions (LISRs) noted at 5-minutes post-injection (time frame: 2-week diaries kept by the patients for Period 1 and for Period 2).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 50 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.