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

NCT02665221 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 15-00173
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Multiple Sclerosis; erythema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  6 Hours

• Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.

  6 Hours

Other Outcomes (1)

• Flu-like Symptom Scale at Last Visit Compared to Base Line.

  6 Hours

Study Arms (2)

Control group

PLACEBO COMPARATOR

Other: No Treatment Arm

Treatment group

EXPERIMENTAL

Drug: Topical Preparation H arm

Interventions

No Treatment Arm OTHER

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

Control group

Topical Preparation H arm DRUG

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Erythema

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shannon Haas
• Organization: MS Comprehensive Care Center NYU Langone Health

Shannon.Haas@nyumc.org

646 501 7504

Study Officials

• Jennifer Kalina

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 18, 2018
• Results First Posted: January 18, 2018

Record last verified: 2017-12

Locations

US (1)