Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, AGEE, histamine response
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).
Interventions
DRUGAGEE 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.
DRUG1% 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.
DRUGtopical placebo cream with no active ingredients
Cream to be applied immediately after injection and repeated as needed.
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed