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Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

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.

NCT02665221•NYU Langone Health

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.
+5 more criteria

Locations (1)

New York University School of Medicine

New York, New York, United States

Key Dates

Start Date

July 1, 2015

Primary Completion Date

September 1, 2016

Completion Date

September 1, 2016

Last Updated

January 18, 2018

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

No Treatment Arm

OTHER

Topical Preparation H arm

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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