Conditions: Epilepsy
Keywords: Brivaracetam Long-term Follow-up Epilepsy Partial Onset Seizures Adjunctive treatment
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

Detailed description:
Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets). The study will continue until either regulatory approval of BRV has been granted by any Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor decides to close the study, or until the BRV development is stopped by the Sponsor.

Arms:
arm 1: At Entry Visit (EV), subjects will start on the individualized Brivaracetam (BRV) dose that they had reached at the completion of the previous study. Dose adjustments of the Investigational Medicinal Product (IMP) are allowed at any time based on the clinical judgment of the investigator. The BRV dose can be increased or decreased in increments of 50 mg/day based on the individual subject's seizure control and/or tolerability; however, the BRV dose should not exceed 200 mg/day during the study and must always be administered as a symmetrical morning and evening dose. Upon completion or early discontinuation from this study, there will be a Down-Titration Period in steps of 50 mg/day on a weekly basis until 20 mg/day for 1 week is reached, followed by a Post-Treatment Period (between 2 and 4 weeks) during which the subject will not receive study drug. No down-Titration Period will be applicable if subjects are continued on BRV after they complete this study.

Interventions: intervention 1: Brivaracetam
Intervention descriptions: intervention 1: Flexible dosing, can up and down-titrate as needed.

Protocol document: