Clinical trial NCT02665221: Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
erythema
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 Hours
Secondary outcomes:
measure: 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.
timeFrame: 6 Hours
measure: Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.
timeFrame: 6 Hours
Other outcomes:
measure: Flu-like Symptom Scale at Last Visit Compared to Base Line.
timeFrame: 6 Hours
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Jennifer Kalina
role: PRINCIPAL_INVESTIGATOR
References: