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Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

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Trial Profile

Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 May 2024

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At a glance

  • Drugs Brivaracetam (Primary)
  • Indications Partial epilepsies; Seizures
  • Focus Adverse reactions; Registrational
  • Sponsors UCB; UCB Pharma SA

Most Recent Events

  • 01 May 2024 Results extending adult PK/PD model to children aged 1 month to < 4 years using information from a combined adult-pediatric PK/PD model for levetiracetam (NCT00175890) and to determine the effective dose of brivaracetam in children aged 1 month to < 4 years (NCT00422422 and NCT01364597) using the adult BRV PK/PD model modified for the basal seizure rate in children, published in the Epilepsy Research.
  • 19 Aug 2023 Results published in the Epilepsia.
  • 27 Apr 2023 Post-hoc analysis results assessing cognitive and behavioral effects of long-term adjunctive brivaracetam (BRV) in children with focal seizures (n=140), presented at the 75th Annual Meeting of the American Academy of Neurology 2023.

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