Back to resultsSingle Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
No Treatment Arm
Topical Preparation H arm
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, erythema
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Treatment group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02665221
Brief Title
Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
It was decided on 9/21/2016 to terminate this study early because LogPad devices the patients used to record their injection data was flawed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, erythema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
No Treatment Arm
Intervention Description
Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
Intervention Type
Drug
Intervention Name(s)
Topical Preparation H arm
Intervention Description
Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Description
Study was terminated. No data analyzed
Time Frame
6 Hours
Title
Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.
Description
Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.
Time Frame
6 Hours
Other Pre-specified Outcome Measures:
Title
Flu-like Symptom Scale at Last Visit Compared to Base Line.
Description
Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.
Time Frame
6 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Kalina
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY
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