Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Flexible dosing, can up and down-titrate as needed.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Long-term Follow-up; Epilepsy; Partial Onset Seizures; Adjunctive treatment

Summary:

      N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of
      Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life
      and to explore the direct medical resource use for BRV (for subjects entering N01372 from a
      study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of
      200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female and 16 years or older. Subjects under 18 years of age may be
             included only where legally permitted and ethically accepted

          -  Subjects having completed the Treatment Period of an applicable previous BRV study,
             and have access to the present study

          -  Subject for whom the investigator believes a reasonable benefit from the long-term
             administration of BRV may be expected

          -  Female subjects without childbearing potential (postmenopausal for at least 2 years,
             bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female
             subjects with childbearing potential are eligible if they use a medically accepted
             contraceptive method

          -  Subjects must be able to take the oral film-coated tablets of BRV

        Exclusion Criteria:

          -  Subject has developed hypersensitivity to any components of the Investigational
             Medicinal Product (IMP) or comparative drugs as stated in the protocol during the
             course of the prior study

          -  Severe medical, neurological, or psychiatric disorders, or laboratory values that 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 (including an actual attempt,
             interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
             months as indicated by a positive response ("Yes") to either question 4 or question 5
             of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the last visit of the
             previous study or at the Entry Visit of this study if not completed at the last visit
             of the previous study