This is a Phase 3, open-label, long-term follow-up (LTFU), multicenter, noncomparative, and
single-arm study of brivaracetam (BRV). The primary objective is to evaluate the long-term
safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in
epilepsy subjects. The secondary objective is to evaluate the maintenance of efficacy of BRV
over time. Exploratory objectives are to assess the effects of BRV on subjects’ Health-related
Quality of Life (HRQoL), obtain information on the direct medical resource use, explore any
change in socio-professional status, and assess the role of gene variants of SV2 in affecting
response to BRV (as part of a DNA analysis at the program level).
This study will enroll subjects (≥16 years) from N01358 with refractory partial onset seizures
(POS) whether or not secondarily generalized. Subjects under 18 years may only be included
where legally permitted and ethically accepted. Subjects have to complete the Treatment
Period of N01358 prior to enrollment into N01379.
Subjects from N01358 will be started on a BRV dose of 150mg/day at study entry and should
be maintained at this dose for at least 2 weeks unless the subject is unable to tolerate
treatment. The BRV dose can be adjusted based on the individual subject’s seizure control and
tolerability. However, the BRV dose may not exceed 200mg/day during the study. During the
Evaluation Period, subjects will be invited to visit the clinical site monthly in the first
3 months and every 3 months thereafter. The completion of the Evaluation Period or early
discontinuation from N01379 is followed by a Down-Titration Period of up to 4 weeks and
by a subsequent Posttreatment Period (between 2 and 4 weeks) during which the subject does
not receive study drug.
Principal Investigator: Matthew Sweney
Department: Pediatric Administration