Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures (BASE)
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
- Patient has never been treated with brivaracetam (BRV) prior to enrollment in this Non-Interventional Study (NIS)
- The decision by the treating physician to prescribe BRV is made independently of the participation in the NIS
- Patient is a male or female ≥16 years of age
- Patient has a clinical diagnosis of epilepsy with partial-onset seizures POS with or without secondary generalization
- Patient uses an epilepsy/seizure diary.
Exclusion criteria
No specific exclusion criteria
Trial design
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Data sourced from clinicaltrials.gov
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