Brivaracetam (2) – Briviact®

• Clinical trials
  • The N01263 trial investigated children and adolescents with epilepsy aged ≥1 month to <16 years who had focal, generalised or unspecified (unclear whether focal or generalised) seizures and who were being treated with at least one and up to a maximum of three anticonvulsants.
  • The Phase III study N01266 is an ongoing long-term study.

Children and adolescents aged 4 to <16 years with focal epileptic seizures, with or without secondary generalisation, as adjunctive therapy

• For children and adolescents aged 4 to <16 years with focal epileptic seizures, with or without secondary generalisation, as adjunctive therapy, the additional benefit is not proven.
• Consequently, no comparative data against the appropriate comparator therapy were presented. An additional benefit of brivaracetam over the appropriate comparator therapy is therefore not proven.
• Summary of the assessment
  • As part of the benefit assessment, two single-arm studies on brivaracetam were submitted.
  • Consequently, there are no comparative data available for brivaracetam as adjunctive therapy for children and adolescents aged 4 to <16 years with focal epileptic seizures, with or without secondary generalisation, compared with the appropriate comparator therapy (individualised adjunctive antiepileptic therapy). An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.