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

NCT02687711 | Completed Results

• 1 other identifier: EP0077
• Study Type: observational
• Target: 544
• Locations: 9 countries
• Sites: 44

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.

Conditions

Epilepsy With POS With or Without Secondary Generalization

Keywords

Non-interventional (NIS); Epilepsy; Partial Onset Seizures (POS); add-on therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (33)

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

  Month 3

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

  Month 6

• Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3

  From Baseline (Day 1) to Month 3

• Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6

  From Baseline (Day 1) to Month 6

• Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12

  From Baseline (Day 1) to Month 12

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead
• Pharm Research Associates Ltd. UK: collaborator

Study Sites (44)

Ep0077 4504

Aarhus, Denmark

Location

Ep0077 4501

Glostrup Municipality, Denmark

Location

Ep0077 4503

Odense, Denmark

Location

Ep0077 4906

Berlin, Germany

Location

Ep0077 4910

Bonn, Germany

Location

Ep0077 4909

Freiburg im Breisgau, Germany

Location

Ep0077 4913

Hamburg, Germany

Location

Ep0077 4901

Kork, Germany

Location

Ep0077 4912

Radeberg, Germany

Location

Ep0077 4904

Ravensburg, Germany

Location

Ep0077 4905

Tübingen, Germany

Location

Ep0077 3605

Budapest, Hungary

Location

Ep0077 3608

Kecskemét, Hungary

Location

Ep0077 3607

Mosdós, Hungary

Location

Ep0077 3602

Nyíregyháza, Hungary

Location

Ep0077 3601

Pécs, Hungary

Location

Ep0077 3606

Szeged, Hungary

Location

Ep0077 3503

Cork, Ireland

Location

Ep0077 3501

Dublin, Ireland

Location

Ep0077 3505

Dublin, Ireland

Location

Ep0077 3912

Florence, Italy

Location

Ep0077 3901

Milan, Italy

Location

Ep0077 3904

Milan, Italy

Location

Ep0077 3902

Verona, Italy

Location

Ep0077 3101

Heeze, Netherlands

Location

Ep0077 3102

Maastricht, Netherlands

Location

Ep0077 4701

Fredrikstad, Norway

Location

Ep0077 3402

A Coruña, Spain

Location

Ep0077 3416

Badajoz, Spain

Location

Ep0077 3412

Córdoba, Spain

Location

Ep0077 3410

Murcia, Spain

Location

Ep0077 4408

Birmingham, United Kingdom

Location

Ep0077 4414

Cardiff, United Kingdom

Location

Ep0077 4406

Dundee, United Kingdom

Location

Ep0077 4401

Glasgow, United Kingdom

Location

Ep0077 4417

Inverness, United Kingdom

Location

Ep0077 4404

Leeds, United Kingdom

Location

Ep0077 4409

London, United Kingdom

Location

Ep0077 4411

London, United Kingdom

Location

Ep0077 4403

Salford, United Kingdom

Location

Ep0077 4407

Sheffield, United Kingdom

Location

Ep0077 4412

Stoke-on-Trent, United Kingdom

Location

Ep0077 4416

Swansea, United Kingdom

Location

Ep0077 4402

Truro, United Kingdom

Location

Related Links

• Product Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: August 4, 2021
• Results First Posted: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); IT (4); IE (3); NL (2); ES (4); DK (3); GB (13); NO (1); HU (6)