Multiple Sclerosis
Conditions
Brief summary
This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.
Interventions
DRUGglatiramer acetate
PROCEDUREWarm compress prior to injection of glatiramer acetate
Sponsors
Teva Neuroscience, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of local injection site reactions (LISRs) noted at 5-minutes post-injection | 2-week diaries kept by the patients for Period 1 and for Period 2 |
Secondary
| Measure | Time frame |
|---|---|
| The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection | 2-week diaries kept by the patients for Period 1 and for Period 2 |
Countries
United States
Outcome results
None listed