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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02665221
Other study ID # 15-00173
Secondary ID
Status Terminated
Phase Phase 4
First received January 22, 2016
Last updated December 18, 2017
Start date July 2015
Est. completion date September 2016

Study information

Verified date December 2017
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Drug:
Topical Preparation H arm
Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Flu-like Symptom Scale at Last Visit Compared to Base Line. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed. 6 Hours
Primary 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 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. Study was terminated. No data analyzed 6 Hours
Secondary Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain. Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed. 6 Hours
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