A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

What Was Tested

In this phase 4 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections.

Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections.

The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.

It had two arms (groups): Copaxone® with Zyrtec (active comparator) and Copaxone® with placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 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: Male or female. 18 years of age or older. Diagnosis of RRMS. Beginning or recently (within \< 3months) began self-injecting Copaxone®.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: taking any other immunomodulatory therapy in conjunction with copaxone®; unable to perform subcutaneous self-injection; pregnant or trying to become pregnant, or breast feeding during the study.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

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 and investigator.

It started in 2004-10 with completion listed for 2006-06.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Injection Site Reaction (time frame: 5 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 80 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.