Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE)

Phase 3

Completed

• Conditions: Epilepsy and epilepsy syndrome

• Registration Number: jRCT2080222434
• Lead Sponsor: UCB Japan Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-25
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 767

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

Study & Design

• Study Type: Interventional
• Study Design: open-label, multicenter, follow-up study

Trial Locations

Locations (1)

Japan/North America/Europe; Location not specified

Japan/North America/Europe