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NCT00988988 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Official title:
The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00988988
Other study ID # 0399-09-FB
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date February 2010
Est. completion date August 3, 2012

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants with multiple sclerosis that are currently treated with glatiramer acetate (GA, Copaxone®) injections and have redness, pain, swelling, itching or a lump at the injection site will be recruited to examine histamine response of three topical treatments to reduce these symptoms.

Description:

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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 3, 2012
Est. primary completion date August 3, 2012
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AGEE cream
AGEE cream is a creatine ethyl ester based product (an amino acid) that can be purchased over-the-counter without a prescription and is not FDA controlled. It will be used immediately after injection and repeated as needed.
• 1% Steroid Cream
comparing to AGEE cream or placebo. 1% steroid cream is available over the counter. To be used immediately after injection and as needed.
• topical placebo cream with no active ingredients
Cream to be applied immediately after injection and repeated as needed.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Nebraska Teva Branded Pharmaceutical Products R&D, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Histamine response after ethyl-a-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate To determine if the use of ethyl-a-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 Three weeks
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