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

NCT ID: NCT02665221

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Group Type: PLACEBO_COMPARATOR

No Treatment Arm

Intervention Type: OTHER

Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.

Treatment group

Group Type: EXPERIMENTAL

Topical Preparation H arm

Intervention Type: DRUG

Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.

Interventions

No Treatment Arm

Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.

Intervention Type: OTHER

Topical Preparation H arm

Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Kalina

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00173

Identifier Type: -

Identifier Source: org_study_id