Overview

The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections

Status:
Withdrawn
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
Participants are asked to be in this study because they have multiple sclerosis, are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site. The purpose of this study is to determine if the use of ethyl-a-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by redness, swelling, and itch response following subcutaneous injection of glatiramer acetate (GA) for the treatment of Multiple Sclerosis (MS).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Nebraska
Collaborators:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Pharmaceutical Industries
Treatments:
Glatiramer Acetate
Criteria
Inclusion Criteria:

- Able to give informed consent

- Between ages 19-65

- Laboratory supported diagnosis of multiple sclerosis

- Currently treated with injectable GA, experiencing wheal and flare after injection

Exclusion Criteria:

- Unable to give informed consent

- Treated with any other therapy for Multiple Sclerosis