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

Primary Purpose

Multiple Sclerosis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
AGEE cream
1% Steroid Cream
topical placebo cream with no active ingredients
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, AGEE, histamine response

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Steroid Cream

    AGEE cream

    placebo

    Arm Description

    1% steroid 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

    inactive cream

    Outcomes

    Primary Outcome Measures

    Histamine response after ethyl-α-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 30, 2009
    Last Updated
    August 18, 2023
    Sponsor
    University of Nebraska
    Collaborators
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00988988
    Brief Title
    The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate Injections
    Official Title
    The Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer Acetate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not approved by IRB
    Study Start Date
    February 2010 (Anticipated)
    Primary Completion Date
    August 3, 2012 (Actual)
    Study Completion Date
    August 3, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska
    Collaborators
    Teva Branded Pharmaceutical Products R&D, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Multiple Sclerosis, AGEE, histamine response

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Steroid Cream
    Arm Type
    Active Comparator
    Arm Description
    1% steroid cream
    Arm Title
    AGEE cream
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    placebo
    Arm Type
    Active Comparator
    Arm Description
    inactive cream
    Intervention Type
    Drug
    Intervention Name(s)
    AGEE cream
    Other Intervention Name(s)
    creatine ethyl ester based topical
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    1% Steroid Cream
    Other Intervention Name(s)
    generic
    Intervention Description
    comparing to AGEE cream or placebo. 1% steroid cream is available over the counter. To be used immediately after injection and as needed.
    Intervention Type
    Drug
    Intervention Name(s)
    topical placebo cream with no active ingredients
    Other Intervention Name(s)
    generic
    Intervention Description
    Cream to be applied immediately after injection and repeated as needed.
    Primary Outcome Measure Information:
    Title
    Histamine response after ethyl-α-guanida-methyl ethanoate (AGEE) and subcutaneous injection of glatiramer acetate
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary Filipi, PhD, APRN
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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