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

Phase 4

Withdrawn

• Conditions: Multiple Sclerosis
• Interventions: Drug: 1% Steroid Cream; Drug: topical placebo cream with no active ingredients; Drug: AGEE cream

• Registration Number: NCT00988988
• Lead Sponsor: University of Nebraska

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Study Start: 2010-02
• Primary Completion: 2012-08-03
• Study Completion: 2012-08-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid Cream	1% Steroid Cream	1% steroid cream
placebo	topical placebo cream with no active ingredients	inactive cream
AGEE cream	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

Primary Outcome Measures

Name	Time	Method
Histamine response after ethyl-α-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate	Three weeks	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