Epilepsy With POS With or Without Secondary GeneralizationBASENCT02687711
Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures
An observational study of Epilepsy With POS With or Without Secondary Generalization, run by UCB Biopharma S.P.R.L. at 44 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy With POS With or Without Secondary Generalization
- How many people
- 544 participants
- Where
- 44 sitesin 9 countries
- Study dates
- 1 Feb 2016to 15 Jul 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (male or female ≥16 years of age) with a clinical diagnosis of epilepsy with Partial Onset Seizures with or without secondary generalization. The patients have never been treated with brivaracetam and the decision by the treating physician (neurologists) to prescribe brivaracetam is made independently of the participation in the study and prior to enrollment. Patient meets the criteria for treatment with brivaracetam as adjunctive therapy according to the current SmPC in Europe. Patient is using a seizure diary as part of their standard of care.
Who may be able to join
- 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.
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
United Kingdom13 sites
Ep0077 4408
Birmingham
Ep0077 4414
Cardiff
Ep0077 4406
Dundee
Ep0077 4401
Glasgow
Ep0077 4417
Inverness
Ep0077 4404
Leeds
Ep0077 4409
London
Ep0077 4411
London
Ep0077 4403
Salford
Ep0077 4407
Sheffield
Ep0077 4412
Stoke-on-Trent
Ep0077 4416
Swansea
Ep0077 4402
Truro
Germany8 sites
Ep0077 4906
Berlin
Ep0077 4910
Bonn
Ep0077 4909
Freiburg im Breisgau
Ep0077 4913
Hamburg
Ep0077 4901
Kork
Ep0077 4912
Radeberg
Ep0077 4904
Ravensburg
Ep0077 4905
Tübingen
Hungary6 sites
Ep0077 3605
Budapest
Ep0077 3608
Kecskemét
Ep0077 3607
Mosdós
Ep0077 3602
Nyíregyháza
Ep0077 3601
Pécs
Ep0077 3606
Szeged
Italy4 sites
Ep0077 3912
Florence
Ep0077 3901
Milan
Ep0077 3904
Milan
Ep0077 3902
Verona
Spain4 sites
Ep0077 3402
A Coruña
Ep0077 3416
Badajoz
Ep0077 3412
Córdoba
Ep0077 3410
Murcia
Denmark3 sites
Ep0077 4504
Aarhus
Ep0077 4501
Glostrup Municipality
Ep0077 4503
Odense
About this study
Official title: 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.
Read the 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.
- Keywords
- Non-interventional (NIS), Epilepsy, Partial Onset Seizures (POS), add-on therapy
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12 (end of Observation Period)
Secondary outcomes (33)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Observation Period (up to Month 12/withdrawal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start1 Feb 2016
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epilepsy With POS With or Without Secondary GeneralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharm Research Associates Ltd. UK
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687711
- Sponsor's protocol ID
- EP0077
- Acronym
- BASE
- Status last verified
- Jul 2021
- First submitted
- 12 Feb 2016
- Last updated
- 4 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02687711
- Acronym / sponsor ID
- BASE / EP0077
- Keywords
- Non-interventional (NIS), Epilepsy, Partial Onset Seizures (POS), add-on therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Collaborators
- Pharm Research Associates Ltd. UK
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Posted 4 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (male or female ≥16 years of age) with a clinical diagnosis of epilepsy with Partial Onset Seizures with or without secondary generalization. The patients have never been treated with brivaracetam and the decision by the treating physician (neurologists) to prescribe brivaracetam is made independently of the participation in the study and prior to enrollment. Patient meets the criteria for treatment with brivaracetam as adjunctive therapy according to the current SmPC in Europe. Patient is using a seizure diary as part of their standard of care.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12
Time frame: 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.
33 secondary outcomes
Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3
Time frame: Month 3
Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6
Time frame: Month 6
Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3
Time frame: From Baseline (Day 1) to Month 3
Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6
Time frame: From Baseline (Day 1) to Month 6
Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12
Time frame: From Baseline (Day 1) to Month 12
Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period
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
Time frame: From Baseline (Day 1) to Month 3
Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6
Time frame: From Baseline (Day 1) to Month 6
Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12
Time frame: From Baseline (Day 1) to Month 12
Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period
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
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
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
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
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
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
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
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
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
Time frame: Month 3
Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3
Time frame: Month 3
Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3
Time frame: Month 3
Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3
Time frame: Month 3
Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6
Time frame: Month 6
Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6
Time frame: Month 6
Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6
Time frame: Month 6
Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6
Time frame: Month 6
Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12
Time frame: Month 12
Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12
Time frame: Month 12
Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12
Time frame: Month 12
Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12
Time frame: Month 12
Time to First Seizure After First Dose of Brivaracetam
Time frame: Month 12
Number of Seizure Free Participants at End of Observation Period
Time frame: End of Observation Period (up to Month 12/withdrawal)
Percent of Seizure Free Participants at End of Observation Period
Time frame: End of Observation Period (up to Month 12/withdrawal)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Product InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 844 599 2273 (UCB)
44 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy With POS With or Without Secondary Generalization, run by UCB Biopharma S.P.R.L. at 44 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United Kingdom, Germany, Hungary, Italy, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 (time frame: Month 12 (end of Observation Period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.