NCT02687711

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 544 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy With POS With or Without Secondary Generalization

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2016-02-22
• Last updated: 2021-08-04
• Results posted: 2021-08-04

Locations

44 sites across 9 countries: Denmark, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Spain, United Kingdom