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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
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator |
| |
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Kalina | New York University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Treatment Group | Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Treatment Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed. | Posted | 6 Hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shannon Haas | MS Comprehensive Care Center NYU Langone Health | 646 501 7504 | Shannon.Haas@nyumc.org |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Topical Preparation H arm | Drug | Preparation H (phenylephrine) treatment first full dose incidence injection site reaction. |
|
Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed. |
| 6 Hours |
Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 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 | Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed. | Posted | 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. | Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed. | Posted | 6 Hours |
|
|
| 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. | Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed. | Posted | 6 Hours |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Treatment Group | Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |