Brimonidine Tartrate for the Treatment of Injection Related Erythema

NCT02568111 | Withdrawn Phase 4

• 2 other identifiers: NLD-PEG-14-107842015-002159-89
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Relapsing-Remitting Multiple Sclerosis (RRMS)

Keywords

erythema; PLEGRIDY; injection site reaction (ISR); MS; RRMS

Outcome Measures

Primary Outcomes (1)

• Change in either Clinician's Erythema Assessment (CEA) or Patient Erythema Self-Assessment (PSA) scale measured as at least 1-grade improvement on CEA and/or at least 1-grade improvement on PSA scale assessed by the physician and participant

  Investigator will evaluate participant's erythema (redness) at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema. Participants rate erythema at the site of injection on a scale of 0 (clear) to 4 (severe) with higher scores indicating higher levels of erythema.

  Before and after 6 hours of gel application

Secondary Outcomes (3)

• Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively

  Before and after 6 hours of gel application

• Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA

  Before and after 6 hours of gel application

• Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale

  Before and after 6 hours of gel application

Study Arms (2)

brimonidine tartrate

EXPERIMENTAL

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

Drug: peginterferon beta-1a; Drug: brimonidine tartrate

Vehicle Gel

PLACEBO COMPARATOR

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

Drug: peginterferon beta-1a; Drug: Vehicle Gel

Interventions

peginterferon beta-1a 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

Also known as: PEGylated Interferon Beta-1a, PEG IFN β-1a, Plegridy, BIIB017

Vehicle Gel; brimonidine tartrate

brimonidine tartrate DRUG

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

Also known as: Mirvaso

brimonidine tartrate

Vehicle Gel DRUG

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

Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Erythema; Injection Site Reaction

Interventions

peginterferon beta-1a; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 5, 2015
• Study Start: February 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 25, 2016

Record last verified: 2016-04