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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
Study is the first study after commercialization of brivaracetam. It is designed to collect real world information on the effectiveness of brivaracetam in patients with Partial Onset Seizure epislepsy who are treated in standard clinical practice.
EP0077 is a 12 months, multicenter, noninterventional study (NIS) conducted at specialized sites in approximately 10 European countries. Patients will be treated according to usual medical diagnostic procedures and therapy; commercially available brivaracetam will be prescribed according to normal clinical practice and the current Summary of Product Characteristics (SmPC) in Europe for brivaracetam (BRV). The prescription of BRV is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients. The primary objective of this study is to determine BRV retention over a 12 month period as a measure of effectiveness in a real world setting. The secondary objective of this study is to assess seizure control with BRV treatment.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Ep0077 4504
Aarhus, Denmark
Ep0077 4501
Glostrup Municipality, Denmark
Ep0077 4503
Odense, Denmark
Ep0077 4906
Berlin, Germany
Ep0077 4910
Bonn, Germany
Ep0077 4909
Freiburg im Breisgau, Germany
Ep0077 4913
Hamburg, Germany
Ep0077 4901
Kork, Germany
Ep0077 4912
Radeberg, Germany
Ep0077 4904
Ravensburg, Germany
Start Date
February 1, 2016
Primary Completion Date
July 15, 2020
Completion Date
July 15, 2020
Last Updated
August 4, 2021
544
ACTUAL participants
Lead Sponsor
UCB Biopharma S.P.R.L.
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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