The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections
Information source: University of Nebraska
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: AGEE cream (Drug); 1% Steroid Cream (Drug); topical placebo cream with no active ingredients (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Nebraska Official(s) and/or principal investigator(s):
Mary Filipi, PhD, APRN, Principal Investigator, Affiliation: University of Nebraska
Overall contact:
Mary Filipi, PhD, APRN, Phone: 402-559-6562, Email: mfilipi@unmc.edu
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).
Clinical Details
Official title: The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To determine if the use of ethyl-α-guanida-methyl ethanoate (AGEE) will decrease histamine response measured by wheal, flare and itch response following subcutaneous injection of glatiramer acetate for the treatment of Multiple Sclerosis
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Mary Filipi, PhD, APRN, Phone: 402-559-6562, Email: mfilipi@unmc.edu
University of Nebraska Medical Center, Omaha, Nebraska 68198-5330, United States
Additional Information
Starting date: February 2010
Last updated: February 11, 2010
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