Text Size

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

This study has been withdrawn prior to enrollment.
(Not approved by IRB)
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00988988
First received: September 30, 2009
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis
 Drug: AGEE cream
Drug: 1% Steroid Cream
Drug: topical placebo cream with no active ingredients
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 [ Time Frame: Three weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steroid Cream
1% steroid cream
 Drug: 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.
Active Comparator: 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
 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.
Active Comparator: placebo
inactive cream
 Drug: topical placebo cream with no active ingredients
Cream to be applied immediately after injection and repeated as needed.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988988

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5330
Sponsors and Collaborators
University of Nebraska
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Mary Filipi, PhD, APRN University of Nebraska
  More Information

No publications provided

Responsible Party: Mary Filipi, Ph.D., APRN Assistant Professor, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00988988     History of Changes
Other Study ID Numbers: 399-09-FB
Study First Received: September 30, 2009
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Multiple Sclerosis
AGEE
histamine response

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 16, 2013