Brimonidine Tartrate for the Treatment of Injection Related Erythema

• Status: Withdrawn
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Brimonidine Tartrate; Interferon beta-1a; Interferon-beta; Interferons

Criteria

Key Inclusion Criteria:

• RRMS patients naïve to treatment with SC interferon or oral and/or IV DMT for which PLEGRIDY is deemed necessary by the treating physician.

• Patient willing and able to complete PSA and PAA questionnaires with minimal assistance.

Key Exclusion Criteria:

• Known allergy to any interferon or any component of peginterferon beta-1a.

• Patients with hypersensitivity to Brimonidine topical gel.

• Patients with other skin disorders.

• History of previous treatment with Brimonidine tartrate.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.