Epilepsy (partial seizures with or without secondary generalization)
Conditions
Interventions
Trade Name: Briviact
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Brivaracetam
CAS Number: 357336-20-0
Current Sponsor code: BRV
Other descriptive name: ucb 34714
Concentration unit: m
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the long-term safety and tolerability of BRV in focal epilepsy subjects with partial seizures;Secondary Objective: Evaluate the maintenance of efficacy of BRV over time;Primary end point(s): 1. Percentage of study participants with treatment-emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1. From baseline until end of the safety follow up (up to 88.5 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period 2. Responder rate in partial seizure frequency per 28 days over the Evaluation Period 3. Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period 4. Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period 5. Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period 6.Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period 7. Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants 8. Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 6 months during the Evaluation Period for directly enrolled study particpants 9. Percentage of participants continuously seizure-free for partial seizure and all seizure types (partial, generalized, and unclassified epileptic seizure) for at least 12 months during the Evaluation Period for directly enrolled study particpants 10. Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants;Timepoint(s) of evaluation of this end point: 1-2. Baseline of EP0083 or N01358 and by every 3-month periods over the Evaluation Period (up to 84 months) 3. During the Evaluation Period (up to 6 months) 4. During the Evaluation Period (up to 12 months) 5. During the Evaluation Period (up to 84 mont | — |
Countries
China, Japan
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed