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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03091569 |
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Date of registration:
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21/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Vitamin K on Redness Associated With Injection Site Reactions in Participants Treated With Plegridy
VITALITY |
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Scientific title:
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Effects of VITAmin K in Lessening Erythema Grade Associated to Injection Site Reactions in Patients Treated With PlegridY (VITALITY) |
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Date of first enrolment:
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March 10, 2017 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03091569 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Relapsing-Remitting Multiple Sclerosis (RRMS) participants for which Plegridy is
deemed necessary by the neurologist. Participants switching from other Disease
Modifying Treatments (DMTs) will be eligible provided that Plegridy is administered at
an injection site different from the previous one.
Key Exclusion Criteria:
- Participants with other skin disorders
- Pregnancy or current breast-feeding
- Depression and other psychiatric disorders
- Unwillingness or inability to comply with the requirements of the protocol.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing-Remitting Multiple Sclerosis
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Intervention(s)
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Other: Placebo Cream
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Other: Vitamin K Cream
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Primary Outcome(s)
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Change in Participants Erythema Self-Assessment (PSA) scale from pre-application of topical cream to 24 hours post-application
[Time Frame: Week 4, week 6, and week 8]
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Change in Clinician's Erythema Assessment (CEA) scale from pre-application of topical cream to 24 hours post-application
[Time Frame: Week 4, week 6, and week 8]
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Secondary Outcome(s)
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Change in Adapted Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) from pre-application of topical cream to 24 hours post-application
[Time Frame: Week 4, week 6, and week 8]
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Change in the longest diameter of erythema from pre-application of topical cream to 24 hours post-application
[Time Frame: Week 4, week 6, and week 8]
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Change in Visual Analogue Scale (VAS) score from pre-application of topical cream to 24 hours post-application
[Time Frame: Week 4, week 6, and week 8]
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Secondary ID(s)
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ITA-PEG-15-10859
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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