Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma SRL
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
