An Open label, Multicentre, Follow up study to evaluate the long term safety and efficacy of Brivaracetam used as adjunctive treatment in subject aged 16 years or older with Epilepsy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 900
- Locations
- 6
- Primary Endpoint
- The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28-day
Study Overview
Brief Summary
UCB is developing BRV(Brivaracetam) as an adjunctive antiepileptic treatment in subjects 16 years and older suffering from focal epilepsy. N01379 will give subjects who have completed N01358 the opportunity to access BRV (Brivaracetam) under the present protocol. N01358 is an adequate and well-controlled study to provide additional data confirming the efficacy and safety of BRV (Brivaracetam) as an AED (Anti Epiletic Drug) in adults (more than or equal to16 years) with refractory POS whether or not secondarily generalized. N01379 will explore the long-term safety and efficacy of BRV (Brivaracetam) in subjects with POS (Partial Onset Seizures) whether or not secondarily generalized while providing access to BRV (Brivaracetam) for subjects who may benefit from open-label treatment with BRV (Brivaracetam) .
Study is globally in recruitment. In India recruitment has started.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 16.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subject completed the Treatment Period of N
- •Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV 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 study 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.
Outcomes
Primary Outcomes
The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28-day
Time Frame: This will be summarized by 3-month periods over the Evaluation Period.
duration.
Time Frame: This will be summarized by 3-month periods over the Evaluation Period.
Secondary Outcomes
- The secondary objective is to evaluate the maintenance of efficacy of(BRV over time.)