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

Teva Neuroscience, Inc.50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

glatiramer acetateDRUG

Warm compress prior to injection of glatiramer acetatePROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or Female, 18 years or older, with a diagnosis of RRMS 2. Willing and able to complete all procedures and evaluations related to the study. 3. Willing to provide Informed Consent Exclusion Criteria: 1. Taking any other immunomodulatory therapy in conjunction with Copaxone®. 2. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study. 3. Any situation which the investigator or nurse feels may interfere with participation in the study. 4. Pregnant, or trying to become pregnant, or breast feeding during the study. 5. Previously participated in this study.

Locations (6)

Fullerton Neurology & Headache Center

Fullerton, California, United States

Neurological Center of South Florida

Miami, Florida, United States

Springfield Neurology Associates

Springfield, Massachusetts, United States

Multiple Sclerosis Care Center

Brooklyn, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection

Time frame: 2-week diaries kept by the patients for Period 1 and for Period 2

Data from ClinicalTrials.gov

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