Relapsing-Remitting Multiple Sclerosis (RRMS) Clinical Trial
Official title:
Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)
The primary objective of this study is to evaluate the Injection Related Erythema (IRE)
mitigation effect of a single administration of brimonidine tartrate in comparison with a
vehicle gel (placebo).
The secondary study objectives are to evaluate the IRE mitigation effect of a single
administration of brimonidine tartrate in comparison with a vehicle gel on a more stringent
definition scale, in accordance with the primary endpoint of the original brimonidine
pivotal trials and participants' satisfaction with the overall appearance of their skin.
Participants naïve to treatment with subcutaneous (SC) interferons or oral Disease Modifying Therapy (DMT) who are about to start PLEGRIDY PEN therapy will be screened for participation in this Phase IV trial. Participants will remain on Plegridy therapy as prescribed by their physician. Plegridy will not be provided to participants by Biogen as a part of this study. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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