NCT02568111

Brimonidine Tartrate for the Treatment of Injection Related Erythema

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

Type	Name	Description
DRUG	peginterferon beta-1a	SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29
DRUG	brimonidine tartrate	Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.
DRUG	Vehicle Gel	Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-10-05
• Last updated: 2016-04-25