Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Epilepsy With POS With or Without Secondary Generalization

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 | Participants who remained in the study and were on BRV treatment for at least 1 year (>=330 days) after their start of BRV were classed as having 12 months of treatment retention. | Month 12 (end of Observation Period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3 | Participants who remained in the study and were on BRV treatment for at least 3 months (>=90 days) after first BRV administration were classed as having 3 months of treatment retention. | Month 3 | 
| Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6 | Participants who remained in the study and were on BRV treatment for at least 6 months (>=180 days) after first BRV administration were classed as having 6 months of treatment retention. | Month 6 | 
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | From Baseline (Day 1) to Month 3 | 
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | From Baseline (Day 1) to Month 6 | 
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | From Baseline (Day 1) to Month 12 | 
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. | From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | 
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | From Baseline (Day 1) to Month 3 | 
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | From Baseline (Day 1) to Month 6 | 
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | From Baseline (Day 1) to Month 12 | 
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | Percent change in POS frequency was defined as: ((28-day Baseline - 28-day post-Baseline seizure frequency)/28-day Baseline) x 100. A positive value indicates a reduction. | From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | 
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | Response was defined as a (greater than or equal to [>=] 50%) reduction from Baseline in seizure frequency. | Baseline (Day 1) to Month 3 | 
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | Baseline (Day 1) to Month 3 | 
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | Baseline (Day 1) to Month 6 | 
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | Baseline (Day 1) to Month 6 | 
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | Baseline (Day 1) to Month 12 | 
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | Response was defined as a >=50% reduction from Baseline in seizure frequency. | Baseline (Day 1) to Month 12 | 
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | Response was defined as a >=50% reduction from Baseline in seizure frequency. | Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | 
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | Response was defined as a >=50% reduction from Baseline in seizure frequency. | Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | 
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 2 [Month 3] = Day 90) were counted as No. | Month 3 | 
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 2 [Month 3] = Day 90) were counted as No. | Month 3 | 
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | Month 3 | 
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | Month 3 | 
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 3 [Month 6] = Day 180) were counted as No. | Month 6 | 
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 3 [Month 6] = Day 180) were counted as No. | Month 6 | 
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | Month 6 | 
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | Month 6 | 
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 4 [Month 12] = Day 330) were counted as No. | Month 12 | 
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date or participants who discontinued BRV or terminated the study prior to the target visit date (Visit 4 [Month 12] = Day 330) were counted as No. | Month 12 | 
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | Month 12 | 
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. Participants with seizures before the visit date were counted as a No. Participants who discontinued BRV or terminated the study prior to the target visit date without any seizures recorded up to discontinuation or termination were excluded from the analysis. | Month 12 | 
| Time to First Seizure After First Dose of Brivaracetam | Time to first seizure was calculated as: Date of first seizure - date of first BRV administration + 1. | Month 12 | 
| Number of Seizure Free Participants at End of Observation Period | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. End of Observation Period (up to Month 12), includes participants who are completers or withdrew early. | End of Observation Period (up to Month 12/withdrawal) | 
| Percent of Seizure Free Participants at End of Observation Period | Seizure freedom (Yes) was defined as having no seizures recorded in the study on or before the visit date, having not discontinued prior to the visit and having available seizure data at the visit. End of Observation Period (up to Month 12), includes participants who are completers or withdrew early. | End of Observation Period (up to Month 12/withdrawal) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Non-interventional (NIS), Partial Onset Seizures (POS), add-on therapy