jRCT2080222434CompletedPhase 3
An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- UCB Japan Co., Ltd.
- Enrollment
- 767
- Locations
- 1
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- Open-label, Multicenter, Follow-up Study
- Primary Purpose
- Treatment Purpose
Eligibility Criteria
- Ages
- 16age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Subject completed the Treatment Period of N01358 or the evaluation period of N01258
- •Subject for whom the Investigator believes a reasonable benefit from the long term administration of Brivaracetam may be expected
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 studies
- •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 study
- •Any medical condition which, in the Investigator's opinion, warrants exclusion
Investigators
Study Sites (1)
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