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

• Occurrence of at least one Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]
• Withdrawal due to Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]
• Occurrence of a Serious Advere Event [ Time Frame: From entry Visit 1 through End of Treatment (up to approximately 4 years) ] [ Designated as safety issue: No ]

• Occurrence of at least one treatment-emergent adverse event during the Evaluation Period (approximately 4 years ) [ Time Frame: From entry Visit 1 through end of treatment (approximately 4 years) ] [ Designated as safety issue: No ]
• Occurrence of discontinuations due to a treatment-emergent adverse event during the Evaluation period (approximately 4 years) [ Time Frame: From entry Visit 1 through end of treatment (up to approximately 4 years) ] [ Designated as safety issue: No ]
• Occurrence of at least one treatment-emergent, drug-related adverse event during the Evaluation period (approximately 4 years) [ Time Frame: From entry Visit 1 through end of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]

• Partial onset seizure (type I) frequency per 28 days during the Evaluation Period [ Time Frame: Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
  28 day adjusted seizure frequency will be calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
• Percent reduction in partial onset seizures (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period [ Time Frame: Baseline from originating study; Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
  Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). Negative changes from Baseline indicate an improvement (ie, a reduction).
• Responder rate in POS (type I) frequency over the Evaluation Period [ Time Frame: Baseline Period: Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). ] [ Designated as safety issue: No ]
  A responder is defined as a subject with a ≥50 % reduction in seizure frequency from the Baseline Period of the previous study.

• Percentage change from Baseline in Type I seizure frequency per 28 days over the Evaluation period (up to approximately 4 years). [ Time Frame: Baseline from originating study; Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
  Baseline is the baseline from subject's original first study of enrollment N01358 - NCT01261325; N01258. 28-day type I seizure frequency is the total number of type I seizures divided by the total number of days evaluated multiplied by 28; negative changes from Baseline indicate an improvement (ie., a reduction)
• Percentage change from Baseline in type I+II+III (all types combined) seizure frequency per 28 days over the Evaluation period (approximately 4 years) [ Time Frame: Baseline from originating study; Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
  Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258. 28-day type I+II+III seizure frequency is the total number of type I+II+III seizures divided by the total number of days evaluated multiplied by 28; negative changes from Baseline indicate an improvement (ie., a reduction)

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

The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

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