Clinical trial NCT02687711: Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy With POS With or Without Secondary Generalization
Keywords: Non-interventional (NIS)
Epilepsy
Partial Onset Seizures (POS)
add-on therapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Pharm Research Associates Ltd. UK
First posted: 2016-02-22
Enrollment: 544
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12
timeFrame: Month 12 (end of Observation Period)
Secondary outcomes:
measure: Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3
timeFrame: Month 3
measure: Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6
timeFrame: Month 6
measure: Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3
timeFrame: From Baseline (Day 1) to Month 3
measure: Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6
timeFrame: From Baseline (Day 1) to Month 6
measure: Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12
timeFrame: From Baseline (Day 1) to Month 12
measure: Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period
timeFrame: From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
measure: Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3
timeFrame: From Baseline (Day 1) to Month 3
measure: Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6
timeFrame: From Baseline (Day 1) to Month 6
measure: Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12
timeFrame: From Baseline (Day 1) to Month 12
measure: Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period
timeFrame: From Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
measure: Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3
timeFrame: Baseline (Day 1) to Month 3
measure: Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3
timeFrame: Baseline (Day 1) to Month 3
measure: Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6
timeFrame: Baseline (Day 1) to Month 6
measure: Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6
timeFrame: Baseline (Day 1) to Month 6
measure: Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12
timeFrame: Baseline (Day 1) to Month 12
measure: Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12
timeFrame: Baseline (Day 1) to Month 12
measure: Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period
timeFrame: Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
measure: Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period
timeFrame: Baseline (Day 1) to end of Observation Period (up to Month 12/withdrawal)
measure: Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3
timeFrame: Month 3
measure: Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3
timeFrame: Month 3
measure: Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3
timeFrame: Month 3
measure: Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3
timeFrame: Month 3
measure: Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6
timeFrame: Month 6
measure: Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6
timeFrame: Month 6
measure: Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6
timeFrame: Month 6
measure: Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6
timeFrame: Month 6
measure: Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12
timeFrame: Month 12
measure: Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12
timeFrame: Month 12
measure: Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12
timeFrame: Month 12
measure: Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12
timeFrame: Month 12
measure: Time to First Seizure After First Dose of Brivaracetam
timeFrame: Month 12
measure: Number of Seizure Free Participants at End of Observation Period
timeFrame: End of Observation Period (up to Month 12/withdrawal)
measure: Percent of Seizure Free Participants at End of Observation Period
timeFrame: End of Observation Period (up to Month 12/withdrawal)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Ep0077 4504
city: Glostrup
country: Denmark
facility: Ep0077 4501
city: Odense
country: Denmark
facility: Ep0077 4503
city: Berlin
country: Germany
facility: Ep0077 4906
city: Bonn
country: Germany
facility: Ep0077 4910
city: Freiburg
country: Germany
facility: Ep0077 4909
city: Hamburg
country: Germany
facility: Ep0077 4913
city: Kork
country: Germany
facility: Ep0077 4901
city: Radeberg
country: Germany
facility: Ep0077 4912
city: Ravensburg
country: Germany
facility: Ep0077 4904
city: Tübingen
country: Germany
facility: Ep0077 4905
city: Budapest
country: Hungary
facility: Ep0077 3605
city: Kecskemét
country: Hungary
facility: Ep0077 3608
city: Mosdós
country: Hungary
facility: Ep0077 3607
city: Nyíregyháza
country: Hungary
facility: Ep0077 3602
city: Pécs
country: Hungary
facility: Ep0077 3601
city: Szeged
country: Hungary
facility: Ep0077 3606
city: Cork
country: Ireland
facility: Ep0077 3503
city: Dublin
country: Ireland
facility: Ep0077 3501
city: Dublin
country: Ireland
facility: Ep0077 3505
city: Firenze
country: Italy
facility: Ep0077 3912
city: Milano
country: Italy
facility: Ep0077 3901
city: Milano
country: Italy
facility: Ep0077 3904
city: Verona
country: Italy
facility: Ep0077 3902
city: Heeze
country: Netherlands
facility: Ep0077 3101
city: Maastricht
country: Netherlands
facility: Ep0077 3102
city: Fredrikstad
country: Norway
facility: Ep0077 4701
city: A Coruña
country: Spain
facility: Ep0077 3402
city: Badajoz
country: Spain
facility: Ep0077 3416
city: Córdoba
country: Spain
facility: Ep0077 3412
city: Murcia
country: Spain
facility: Ep0077 3410
city: Birmingham
country: United Kingdom
facility: Ep0077 4408
city: Cardiff
country: United Kingdom
facility: Ep0077 4414
city: Dundee
country: United Kingdom
facility: Ep0077 4406
city: Glasgow
country: United Kingdom
facility: Ep0077 4401
city: Inverness
country: United Kingdom
facility: Ep0077 4417
city: Leeds
country: United Kingdom
facility: Ep0077 4404
city: London
country: United Kingdom
facility: Ep0077 4409
city: London
country: United Kingdom
facility: Ep0077 4411
city: Salford
country: United Kingdom
facility: Ep0077 4403
city: Sheffield
country: United Kingdom
facility: Ep0077 4407
city: Stoke-on-Trent
country: United Kingdom
facility: Ep0077 4412
city: Swansea
country: United Kingdom
facility: Ep0077 4416
city: Truro
country: United Kingdom
facility: Ep0077 4402
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: