Status:
COMPLETED
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
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Partial Seizures With or Without Secondary Generalization
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2024
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT03250377
Start Date
August 5 2017
End Date
December 24 2024
Last Update
July 29 2025
Active Locations (59)
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1
Ep0085 905
Beijing, China
2
Ep0085 901
Chengdu, China
3
Ep0085 902
Guangzhou, China
4
Ep0085 909
Guangzhou, China