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

NCT00988988 | Withdrawn Phase 4

• 1 other identifier: 0399-09-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; AGEE; histamine response

Outcome Measures

Primary Outcomes (1)

• 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

  Three weeks

Study Arms (3)

Steroid Cream

ACTIVE COMPARATOR

1% steroid cream

Drug: 1% Steroid Cream

AGEE cream

ACTIVE COMPARATOR

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

placebo

ACTIVE COMPARATOR

inactive cream

Drug: topical placebo cream with no active ingredients

Interventions

AGEE cream DRUG

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.

Also known as: creatine ethyl ester based topical

AGEE cream

1% Steroid Cream DRUG

comparing to AGEE cream or placebo. 1% steroid cream is available over the counter. To be used immediately after injection and as needed.

Also known as: generic

Steroid Cream

topical placebo cream with no active ingredients DRUG

Cream to be applied immediately after injection and repeated as needed.

Also known as: generic

placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent
• Treated with any other therapy for Multiple Sclerosis

Sponsors & Collaborators

• University of Nebraska: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Drugs, Generic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Mary Filipi, PhD, APRN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 2, 2009
• Study Start: February 1, 2010
• Primary Completion: August 3, 2012
• Study Completion: August 3, 2012
• Last Updated: August 23, 2023

Record last verified: 2023-08