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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT02568111 |
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Date of registration:
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01/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Brimonidine Tartrate for the Treatment of Injection Related Erythema
BRITE |
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Scientific title:
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Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated With Sub-cutaneous Administration of Peginterferon Beta-1a (BRITE) |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02568111 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Relapsing-Remitting Multiple Sclerosis (RRMS)
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Intervention(s)
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Drug: Vehicle Gel
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Drug: brimonidine tartrate
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Drug: peginterferon beta-1a
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Primary Outcome(s)
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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
[Time Frame: Before and after 6 hours of gel application]
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Secondary Outcome(s)
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Participant's self-assessment of satisfaction with the overall appearance of their skin by using a Patient's Assessment of Appearance (PAA) grading scale
[Time Frame: Before and after 6 hours of gel application]
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Composite change in both CEA and PSA scale measured as at least 2-grade improvement on CEA and 2-grade improvement on PSA
[Time Frame: Before and after 6 hours of gel application]
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Composite change in both CEA and PSA scale measured as at least 1-grade improvement on CEA and 1-grade improvement on PSA respectively
[Time Frame: Before and after 6 hours of gel application]
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Secondary ID(s)
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NLD-PEG-14-10784
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2015-002159-89
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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