NCT03250377CompletedPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (actual)
- First submitted
- 31 Jul 2017
- Start date
- 5 Aug 2017
- Primary completion date
- 24 Dec 2024
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Epilepsy
- NCT number
- NCT03250377
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 207
- From 5 Aug 2017 to the primary completion date, 24 Dec 2024
- 59 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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)
Other
- Pregnant or lactating woman
Who the study is looking for
- 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (59)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.