Viewing Study NCT00988988



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Last Modification Date: 2024-10-26 @ 10:11 AM
Study NCT ID: NCT00988988
Status: WITHDRAWN
Last Update Posted: 2023-08-23
First Post: 2009-09-30

Brief Title: The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections
Sponsor: University of Nebraska
Organization: University of Nebraska

Study Overview

Official Title: The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate
Status: WITHDRAWN
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not approved by IRB
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None