Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, erythema
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.
Interventions
OTHERNo Treatment Arm
Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
DRUGTopical Preparation H arm
Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Study was terminated. No data analyzed |
| Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain. | 6 Hours | Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Flu-like Symptom Scale at Last Visit Compared to Base Line. | 6 Hours | Study was terminated. No data analyzed because the Logpad being used by subjects was flawed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group 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. | 15 |
| Treatment Group Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 9 Participants | 23 Participants |
| Region of Enrollment United States | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: 6 Hours
Population: Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.
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.
Time frame: 6 Hours
Population: Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.
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
Time frame: 6 Hours
Population: Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.
Other Pre-specified
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.
Time frame: 6 Hours
Population: Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.