Brimonidine Tartrate for the Treatment of Injection Related Erythema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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

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Relapsing-Remitting Multiple Sclerosis (RRMS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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brimonidine tartrate

Participants will apply gel to injection site erythema area after IRE development post peginterferon beta-1a injection

Group Type EXPERIMENTAL

peginterferon beta-1a

Intervention Type DRUG

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

brimonidine tartrate

Intervention Type DRUG

Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.

Vehicle Gel

Participants will apply vehicle gel placebo to injection site erythema area after IRE development post peginterferon beta-1a injection

Group Type PLACEBO_COMPARATOR

peginterferon beta-1a

Intervention Type DRUG

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

Vehicle Gel

Intervention Type DRUG

Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.

Interventions

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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

Intervention Type DRUG

brimonidine tartrate

Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.

Intervention Type DRUG

Vehicle Gel

Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.

Intervention Type DRUG

Other Intervention Names

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PEGylated Interferon Beta-1a PEG IFN β-1a Plegridy BIIB017 Mirvaso

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No