Epilepsy With POS With or Without Secondary Generalization
Conditions
Keywords
Non-interventional (NIS), Epilepsy, Partial Onset Seizures (POS), add-on therapy
Brief summary
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
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.
Interventions
None listed
Sponsors
Pharm Research Associates Ltd. UK
UCB Biopharma S.P.R.L.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 | Month 12 (end of Observation Period) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6 | 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. |
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | From Baseline (Day 1) to Month 3 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. |
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | From Baseline (Day 1) to Month 6 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. |
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | From Baseline (Day 1) to Month 12 | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. |
| Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency. |
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | From Baseline (Day 1) 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. |
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | From Baseline (Day 1) 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. |
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | From Baseline (Day 1) 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. |
| Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | 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. |
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | Baseline (Day 1) to Month 3 | Response was defined as a (greater than or equal to \[\>=\] 50%) reduction from Baseline in seizure frequency. |
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | Baseline (Day 1) to Month 3 | Response was defined as a \>=50% reduction from Baseline in seizure frequency. |
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | Baseline (Day 1) to Month 6 | Response was defined as a \>=50% reduction from Baseline in seizure frequency. |
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | Baseline (Day 1) to Month 6 | Response was defined as a \>=50% reduction from Baseline in seizure frequency. |
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | Baseline (Day 1) to Month 12 | Response was defined as a \>=50% reduction from Baseline in seizure frequency. |
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | Baseline (Day 1) to Month 12 | Response was defined as a \>=50% reduction from Baseline in seizure frequency. |
| Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | Response was defined as a \>=50% reduction from Baseline in seizure frequency. |
| Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3 | 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. |
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | 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. |
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | 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. |
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | 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. |
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | 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. |
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | 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. |
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | 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. |
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | 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. |
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | 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. |
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | 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. |
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | 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. |
| Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | 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. |
| Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | 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 to First Seizure After First Dose of Brivaracetam | Month 12 | Time to first seizure was calculated as: Date of first seizure - date of first BRV administration + 1. |
| Number of Seizure Free Participants at End of Observation Period | End of Observation Period (up to Month 12/withdrawal) | 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. |
| Percent of Seizure Free Participants at End of Observation Period | End of Observation Period (up to Month 12/withdrawal) | 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. |
| Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal) | Response was defined as a \>=50% reduction from Baseline in seizure frequency. |
Countries
Denmark, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Spain, United Kingdom
Participant flow
Recruitment details
The study started to enroll participants in February 2016 and concluded in July 2020.
Pre-assignment details
Participant Flow refers to the Safety Set.
Participants by arm
| Arm | Count |
|---|---|
| Brivaracetam (BRV) Participants were treated with commercially available BRV as prescribed by treating physicians, in accordance with current clinical practice and in accordance with the approved European Summary of Product Characteristics (SmPC). | 544 |
| Total | 544 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 89 |
| Overall Study | Change of Hospital | 1 |
| Overall Study | Consent withdrawn | 15 |
| Overall Study | Diagnosis epilepsy revised to psychogenic seizures | 1 |
| Overall Study | Disliked taste | 1 |
| Overall Study | Lack of Efficacy | 70 |
| Overall Study | Liver Encephalopathy | 1 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Low mood | 1 |
| Overall Study | Participant experience side effects, fatigue. Most likely not related to investigational product | 1 |
| Overall Study | Participant moved abroad | 1 |
| Overall Study | Participant moved to another country and continued treatment for epilepsy in that country | 1 |
| Overall Study | Participant was not able to come in our clinic because participant could not find a car driver | 1 |
| Overall Study | Perceived increase in seizures but diary records show no increase compared to pre-study | 1 |
| Overall Study | Progression of other medical condition (dementia, pneumonia) | 1 |
| Overall Study | Side effects | 1 |
| Overall Study | Stopped in preparation for epilepsy surgery | 1 |
| Overall Study | Too expensive | 4 |
| Overall Study | Withdrawn due to intake interruption | 1 |
Baseline characteristics
| Characteristic | Brivaracetam (BRV) | — |
|---|---|---|
| Age, Categorical <=18 years | 8 Participants | — |
| Age, Categorical >=65 years | 44 Participants | — |
| Age, Categorical Between 18 and 65 years | 492 Participants | — |
| Age, Continuous | 43.6 years STANDARD_DEVIATION 14.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 287 Participants | — |
| Sex: Female, Male Male | 257 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 544 |
| other Total, other adverse events | 62 / 544 |
| serious Total, serious adverse events | 80 / 544 |
Outcome results
Primary
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)
Population: The Full Analysis Set (FAS) was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this non interventional study (NIS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 | 57.7 percentage of participants |
Secondary
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)
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | 1.69 seizures per 28 days | Standard Deviation 26.59 |
Secondary
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.
Time frame: From Baseline (Day 1) to Month 12
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | 3.75 seizures per 28 days | Standard Deviation 16.05 |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | 4.54 seizures per 28 days | Standard Deviation 24.34 |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | 3.29 seizures per 28 days | Standard Deviation 16.92 |
Secondary
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)
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | 175 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | 139 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | 170 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | 146 Participants |
Secondary
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)
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Seizure Free Participants at End of Observation Period | NA Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | 37 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | 81 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | 54 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | 37 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | 81 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam (FAS) | Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | 54 Participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3 | 82.4 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6 | 70.6 percentage of participants |
Secondary
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)
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period | -9.54 percent change | Standard Deviation 308.89 |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 | 7.05 percent change | Standard Deviation 351.75 |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 | -5.39 percent change | Standard Deviation 215.31 |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam (FAS) | Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 | -10.64 percent change | Standard Deviation 369.03 |
Secondary
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)
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment and were classified as study completers or who withdrew early.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period | 51.6 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 | 60.4 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 | 47.0 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 | 47.4 percentage of participants |
Secondary
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)
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Seizure Free Participants at End of Observation Period | NA percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 | 13.8 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 | 17.8 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 | 11.8 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 | 13.8 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 | 16.3 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS. Here number of participants were included who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brivaracetam (FAS) | Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 | 10.6 percentage of participants |
Secondary
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
Population: FAS was defined as all participants in the Safety Set (SS) who did not receive BRV before entering this NIS.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brivaracetam (FAS) | Time to First Seizure After First Dose of Brivaracetam | 15 days |