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

• Status: Enrolling by invitation
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Treatments: Brivaracetam

Criteria

Inclusion Criteria:

• Male/female subject from 16 years of age or older. Subjects who are not legal adults may only be included where legally permitted and ethically accepted

• Subject completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan

• Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion Criteria:

• Subject 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 subject

• 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

• Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months

• Subject 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)