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

Korábbi kezelés

• 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

Más betegség

• 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
• 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

Laborértékek

• Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant
• 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)

Egyéb

• Pregnant or lactating woman

• 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