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

• Status: Completed
• Trial end date: 2019-04-18
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB BIOSCIENCES, Inc.
• Treatments: Brivaracetam

Criteria

Inclusion Criteria:

• Subject completed the Treatment Period of N01358 or the evaluation period of N01258

• Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted

• Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected

• Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

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

• 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

• Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months