BRITE
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Peginterferon beta-1a
Interferon alpha/beta receptor agonist
- Brimonidine
Placebo or sham
- Vehicle Gel
What it measured
Main measures
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
Before and after 6 hours of gel application
Other measures (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
Quality of life (reported by participants)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
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Feb 2016
Main results due
Aug 2016
Finished
Aug 2016
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