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Completed

NCT Number: NCT02687711

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

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.

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Key information

Conditions

Epilepsy With POS With or Without Secondary Generalization Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ep0077 4504, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3

    Time frame: 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.

  2. Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6

    Time frame: 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.

  3. 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 POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

  4. 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 POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

  5. 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 POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

  6. 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)

    Absolute change in POS frequency was defined as: 28-day Baseline - 28-day post-Baseline seizure frequency.

  7. 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 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.

  8. 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 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.

  9. 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 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.

  10. 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)

    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.

  11. 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

    Response was defined as a (greater than or equal to [>=] 50%) reduction from Baseline in seizure frequency.

  12. 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

    Response was defined as a >=50% reduction from Baseline in seizure frequency.

  13. 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

    Response was defined as a >=50% reduction from Baseline in seizure frequency.

  14. 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

    Response was defined as a >=50% reduction from Baseline in seizure frequency.

  15. 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

    Response was defined as a >=50% reduction from Baseline in seizure frequency.

  16. 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

    Response was defined as a >=50% reduction from Baseline in seizure frequency.

  17. 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)

    Response was defined as a >=50% reduction from Baseline in seizure frequency.

  18. 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)

    Response was defined as a >=50% reduction from Baseline in seizure frequency.

  19. Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3

    Time frame: 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.

  20. Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3

    Time frame: 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.

  21. Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3

    Time frame: 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.

  22. Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3

    Time frame: 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.

  23. Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6

    Time frame: 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.

  24. Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6

    Time frame: 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.

  25. Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6

    Time frame: 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.

  26. Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6

    Time frame: 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.

  27. Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12

    Time frame: 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.

  28. Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12

    Time frame: 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.

  29. Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12

    Time frame: 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.

  30. Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12

    Time frame: 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.

  31. Time to First Seizure After First Dose of Brivaracetam

    Time frame: Month 12

    Time to first seizure was calculated as: Date of first seizure - date of first BRV administration + 1.

  32. Number of Seizure Free Participants at End of Observation Period

    Time frame: 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.

  33. Percent of Seizure Free Participants at End of Observation Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Collaborators

  • Pharm Research Associates Ltd. UK

Registry information

Official study 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

Acronym: BASE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2016
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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