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

Epilepsy With POS With or Without Secondary Generalization Clinical Trial

— BASE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687711
• Other study ID #: EP0077
• Status: Completed
• Start date: February 1, 2016
• Est. completion date: July 15, 2020

Study information

• Verified date: July 2021
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy With POS With or Without Secondary Generalization
• Seizures

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.	Pharm Research Associates (UK) Ltd.

Countries where clinical trial is conducted

Denmark,  Germany,  Hungary,  Ireland,  Italy,  Netherlands,  Norway,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Month 12 (end of Observation Period)
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.	Month 3
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.	Month 6
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.	From Baseline (Day 1) to Month 3
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.	From Baseline (Day 1) to Month 6
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.	From Baseline (Day 1) to Month 12
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.	From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
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.	From Baseline (Day 1) to Month 3
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.	From Baseline (Day 1) to Month 6
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.	From Baseline (Day 1) to Month 12
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.	From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
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.	Baseline (Day 1) to Month 3
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.	Baseline (Day 1) to Month 3
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.	Baseline (Day 1) to Month 6
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.	Baseline (Day 1) to Month 6
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.	Baseline (Day 1) to Month 12
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.	Baseline (Day 1) to Month 12
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.	Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
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.	Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
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.	Month 3
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.	Month 3
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.	Month 3
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.	Month 3
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.	Month 6
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.	Month 6
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.	Month 6
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.	Month 6
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.	Month 12
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.	Month 12
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.	Month 12
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.	Month 12
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.	Month 12
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.	End of Observation Period (up to Month 12/withdrawal)
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.	End of Observation Period (up to Month 12/withdrawal)

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