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.
Study Type
OBSERVATIONAL
Enrollment
544
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.
Time frame: Month 12 (end of Observation Period)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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
...and 34 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of Observation Period (up to Month 12/withdrawal)