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

NCT ID: NCT02687711

Last Updated: 2021-08-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

544 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-01

Study Completion Date

2020-07-15

Brief Summary

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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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Partial Seizures With or Without Secondary Generalization Epilepsy
COMPLETED PHASE3

This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

NCT00150800

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A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

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Detailed Description

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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.

Conditions

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Epilepsy With POS With or Without Secondary Generalization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharm Research Associates Ltd. UK

INDUSTRY

Sponsor Role collaborator

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

+1 844 599 2273 (UCB)

Locations

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Ep0077 4504

Aarhus, , Denmark

Site Status

Ep0077 4501

Glostrup Municipality, , Denmark

Site Status

Ep0077 4503

Odense, , Denmark

Site Status

Ep0077 4906

Berlin, , Germany

Site Status

Ep0077 4910

Bonn, , Germany

Site Status

Ep0077 4909

Freiburg im Breisgau, , Germany

Site Status

Ep0077 4913

Hamburg, , Germany

Site Status

Ep0077 4901

Kork, , Germany

Site Status

Ep0077 4912

Radeberg, , Germany

Site Status

Ep0077 4904

Ravensburg, , Germany

Site Status

Ep0077 4905

Tübingen, , Germany

Site Status

Ep0077 3605

Budapest, , Hungary

Site Status

Ep0077 3608

Kecskemét, , Hungary

Site Status

Ep0077 3607

Mosdós, , Hungary

Site Status

Ep0077 3602

Nyíregyháza, , Hungary

Site Status

Ep0077 3601

Pécs, , Hungary

Site Status

Ep0077 3606

Szeged, , Hungary

Site Status

Ep0077 3503

Cork, , Ireland

Site Status

Ep0077 3501

Dublin, , Ireland

Site Status

Ep0077 3505

Dublin, , Ireland

Site Status

Ep0077 3912

Florence, , Italy

Site Status

Ep0077 3901

Milan, , Italy

Site Status

Ep0077 3904

Milan, , Italy

Site Status

Ep0077 3902

Verona, , Italy

Site Status

Ep0077 3101

Heeze, , Netherlands

Site Status

Ep0077 3102

Maastricht, , Netherlands

Site Status

Ep0077 4701

Fredrikstad, , Norway

Site Status

Ep0077 3402

A Coruña, , Spain

Site Status

Ep0077 3416

Badajoz, , Spain

Site Status

Ep0077 3412

Córdoba, , Spain

Site Status

Ep0077 3410

Murcia, , Spain

Site Status

Ep0077 4408

Birmingham, , United Kingdom

Site Status

Ep0077 4414

Cardiff, , United Kingdom

Site Status

Ep0077 4406

Dundee, , United Kingdom

Site Status

Ep0077 4401

Glasgow, , United Kingdom

Site Status

Ep0077 4417

Inverness, , United Kingdom

Site Status

Ep0077 4404

Leeds, , United Kingdom

Site Status

Ep0077 4409

London, , United Kingdom

Site Status

Ep0077 4411

London, , United Kingdom

Site Status

Ep0077 4403

Salford, , United Kingdom

Site Status

Ep0077 4407

Sheffield, , United Kingdom

Site Status

Ep0077 4412

Stoke-on-Trent, , United Kingdom

Site Status

Ep0077 4416

Swansea, , United Kingdom

Site Status

Ep0077 4402

Truro, , United Kingdom

Site Status

Countries

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Denmark Germany Hungary Ireland Italy Netherlands Norway Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.briviact.com/briviact-PI.pdf?v=1479491757

Product Information

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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EP0077

Identifier Type: -

Identifier Source: org_study_id

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