Brivaracetam (3) – Briviact®

• Clinical trials
  • Study N01263 is a single-arm Phase 2a study investigating the pharmacokinetics, safety and efficacy of brivaracetam in children and adolescents with epilepsy.
  • Study EP0065 is a single-arm Phase 2 study investigating the pharmacokinetics and safety of brivaracetam administered as a 15-minute infusion and bolus infusion in children and adolescents with epilepsy.
  • Study N01266 is a long-term Phase 3 clinical development study which, amongst others, included children and adolescents who had previously taken part in other studies with brivaracetam.

Children aged 2 to < 4 years with focal epileptic seizures, with or without secondary generalisation, as adjunctive therapy

• The additional benefit is not proven.
• No relevant RCT was identified for the assessment of additional benefit in which brivaracetam was compared with the appropriate comparator therapy.
• The pharmaceutical manufacturer therefore submits the non-comparative single-arm study N01266 on brivaracetam.
• As the single-arm study N01266 does not allow for a direct comparison of brivaracetam with the appropriate comparator therapy, the data are not suitable for assessing the additional benefit of brivaracetam.
• Furthermore, only four patients in study N01266 meet the criteria for the intended therapeutic indication in terms of age and seizure type.

Courtesy translation only, please refer to the German original.