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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02665221
• Date of registration: 22/01/2016
• Prospective Registration: No
• Primary sponsor: New York University School of Medicine
• Public title: Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY
• Scientific 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.
• Date of first enrolment: July 2015
• Target sample size: 32
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02665221
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Jennifer Kalina
• Affiliation: New York University Medical School

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Topical Preparation H arm

Other: No Treatment Arm

Primary Outcome(s)

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. [Time Frame: 6 Hours]

Secondary Outcome(s)

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. [Time Frame: 6 Hours]

Number of patients experiencing injection site reaction erythema, itching and pain. [Time Frame: 6 Hours]

Secondary ID(s)

15-00173

Source(s) of Monetary Support

Please refer to primary and secondary sponsors