EP0085
EP0085
An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age with Partial Seizures With or Without Secondary Generalization
Brief 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.
Medical Condition
Partial seizures with or without secondary generalization
Min. Age
16
Years
Max. Age
-
Who Can Join?
All
Status
Enrolling by invitation
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)
Study Medication Description
Study Medication:
Briviact®
Other Descriptive Name:
brivaracetam
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
August 2017
Actual Start Date of Enrollment
March 2025
Planned Study Completion Date
General Information
Study ID:
EP0085
EudraCT Number:
2019-001205-25
CT.gov Number:
NCT03250377
Phase:
Phase 3