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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy With POS With or Without Secondary Generalization

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 Type: Observational
• Enrollment (Actual): 544

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Ep0077 4504
  • Glostrup, Denmark
    • Ep0077 4501
  • Odense, Denmark
    • Ep0077 4503
• Germany
  • Berlin, Germany
    • Ep0077 4906
  • Bonn, Germany
    • Ep0077 4910
  • Freiburg, Germany
    • Ep0077 4909
  • Hamburg, Germany
    • Ep0077 4913
  • Kork, Germany
    • Ep0077 4901
  • Radeberg, Germany
    • Ep0077 4912
  • Ravensburg, Germany
    • Ep0077 4904
  • Tübingen, Germany
    • Ep0077 4905
• Hungary
  • Budapest, Hungary
    • Ep0077 3605
  • Kecskemét, Hungary
    • Ep0077 3608
  • Mosdós, Hungary
    • Ep0077 3607
  • Nyíregyháza, Hungary
    • Ep0077 3602
  • Pécs, Hungary
    • Ep0077 3601
  • Szeged, Hungary
    • Ep0077 3606
• Ireland
  • Cork, Ireland
    • Ep0077 3503
  • Dublin, Ireland
    • Ep0077 3501
  • Dublin, Ireland
    • Ep0077 3505
• Italy
  • Firenze, Italy
    • Ep0077 3912
  • Milano, Italy
    • Ep0077 3901
  • Milano, Italy
    • Ep0077 3904
  • Verona, Italy
    • Ep0077 3902
• Netherlands
  • Heeze, Netherlands
    • Ep0077 3101
  • Maastricht, Netherlands
    • Ep0077 3102
• Norway
  • Fredrikstad, Norway
    • Ep0077 4701
• Spain
  • A Coruña, Spain
    • Ep0077 3402
  • Badajoz, Spain
    • Ep0077 3416
  • Córdoba, Spain
    • Ep0077 3412
  • Murcia, Spain
    • Ep0077 3410
• United Kingdom
  • Birmingham, United Kingdom
    • Ep0077 4408
  • Cardiff, United Kingdom
    • Ep0077 4414
  • Dundee, United Kingdom
    • Ep0077 4406
  • Glasgow, United Kingdom
    • Ep0077 4401
  • Inverness, United Kingdom
    • Ep0077 4417
  • Leeds, United Kingdom
    • Ep0077 4404
  • London, United Kingdom
    • Ep0077 4409
  • London, United Kingdom
    • Ep0077 4411
  • Salford, United Kingdom
    • Ep0077 4403
  • Sheffield, United Kingdom
    • Ep0077 4407
  • Stoke-on-Trent, United Kingdom
    • Ep0077 4412
  • Swansea, United Kingdom
    • Ep0077 4416
  • Truro, United Kingdom
    • Ep0077 4402

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.
• Collaborators: Pharm Research Associates (UK) Ltd.

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Epilepsy; add-on therapy; Non-interventional (NIS); Partial Onset Seizures (POS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: EP0077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.