A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

UCB

Status and phase

Completed

Phase 3

Conditions

Partial Seizures With or Without Secondary Generalization

Epilepsy

Treatments

Drug: Brivaracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT03250377

EP0085

Details and patient eligibility

About

The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.

Enrollment

207 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male/female study participant from 16 years of age or older. Study participant who are not legal adults may only be included where legally permitted and ethically accepted
Study participant completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
Female study participants with childbearing potential are eligible if they use a medically accepted contraceptive method
Inclusion Criteria for directly enrollers only: Study participant has 1 to <8 partial seizures (according to the 1981 International League Against Epilepsy (ILAE) classification) during the 8 weeks prior to brivaracetam (BRV) administration

Exclusion criteria

Study participant has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant
Poor compliance with the visit schedule or medication intake in the previous BRV studies
Planned participation in any other clinical study of another investigational drug or device during this study
Pregnant or lactating woman
Any medical condition which, in the Investigator's opinion, warrants exclusion
Study participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Study participant has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)