Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY

Study Overview
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Brief Summary
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The primary purpose of this single center, randomized, open label study in relapsing Multiple Sclerosis (MS) patients on PLEGRIDY (peginterferon beta-1a) is to assess the effect of Preparation H (phenylephrine) Maximum Strength Cream compared to no topical treatment of injection site erythema after PLEGRIDY injection.

Official Title
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Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: No Treatment Arm
* Drug: Topical Preparation H arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed diagnosis of relapsing multiple sclerosis, as defined by McDonald criteria. Age 18 to 70 years old, inclusive, at the time of informed consent. Naïve to PLEGRIDY or less than or equal to 12 months on PLEGRIDY therapy. Exclusion Criteria: Primary progressive, secondary progressive or progressive relapsing MS. Concurrent enrollment in any clinical trial of an investigational product. Known allergy to any interferon or any component of PLEGRIDY (peginterferon beta-1a). Known allergy to phenylephrine, pramoxane or any component of Preparation H. History of hypersensitivity or intolerance to naproxen or acetaminophen (Tylenol) that would preclude the use of at least 1 of these during the study. History of inadequate response to subcutaneous interferon beta therapy. History of human immunodeficiency virus, hepatitis C virus antibody or current hepatitis B infection. History of premalignant and malignant disease including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured). History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator. History of seizure disorder or unexplained blackouts. History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia), at the discretion of the Investigator, within 3 months prior to Day 1. History of drug or alcohol abuse (as defined by the Investigator) within 6 months prior to Day. Active bacterial or viral infection. Inability to comply with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br> | Other: No Treatment Arm<br>* Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.<br>|
| Experimental: Treatment group<br> | Drug: Topical Preparation H arm<br>* Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Erythema Self-Assessment (PSA) Score 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline PSA Score of Injection Site Erythema at Least 2 Hours After PLEGRIDY Injection. |  | 6 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Width of Injection Site Erythema in Millimeters 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline Width of Injection Site Erythema at Least 2 Hours After Injection. | Study was terminated. No data analyzed | 6 Hours | 
| Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain. | Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed. | 6 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, erythema