BASE: Brivaracetam And Seizure reduction in Epilepsy (PR STUDY - SYSTEM CANNOT BE CHANGED)
Research type
Research Study
Full title
A 12-MONTH NONINTERVENTIONAL, POSTMARKETING, MULTICENTER STUDY TO EVALUATE THE EFFECTIVENESS OF BRIVIACT® (BRIVARACETAM) AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY WITH PARTIAL-ONSET SEIZURES IN DAILY CLINICAL PRACTICE
IRAS ID
196924
Contact name
John Leach
Contact email
Sponsor organisation
UCB BIOPHARMA SPRL
Duration of Study in the UK
3 years, 0 months, 12 days
Research summary
Briviact® (brivaracetam [BRV]) was submitted for Marketing Authorisation Application to the European Medicines Agency as adjunctive therapy in the treatment of partial-onset seizures (POS) with or without secondary generalization in patients 16 years of age and older with epilepsy. The efficacy of BRV for the adjunctive therapy of POS was established in 3 Phase 3 studies in subjects 16 years of age and older. study will be started in parallel with the drug launch in the countries including UK, to collect first real world data. EP0077 is the first postauthorization observational study of BRV in the real world, and is designed to collect information on the effectiveness in patients with POS who are treated with BRV in clinical practice after the product is marketed in the European Union. EP0077 is a postmarketing, multinational, multicenter, noninterventional study (NIS) conducted at specialized sites in approximately 10 European countries, with a 12-month Observation Period. Medical chart data and questionnaires will be collected within the course of the study. Routine visits will be used, there will be no additional visits, procedures requested due to participation in the study.
REC name
West of Scotland REC 3
REC reference
16/WS/0013
Date of REC Opinion
12 Feb 2016
REC opinion
Further Information Favourable Opinion