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Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy

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Trial Profile

Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 May 2024

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At a glance

  • Drugs Brivaracetam (Primary)
  • Indications Epilepsy
  • Focus Pharmacokinetics
  • Sponsors UCB

    • 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.
    • 26 Apr 2022 Interim results of post-hoc pooled analysis assessing cognitive/behavioral effects and tolerability of long-term adjunctive brivaracetam (BRV) in children/adolescents with focal seizures (N01263/NCT00422422 & N01266/NCT01364597) presented at the 74th Annual Meeting of the American Academy of Neurology 2022
    • 24 Jun 2020 According to a UCB media release, interim subgroup analysis of pooled data from (NCT00422422 and NCT01364597) published in the online supplement to Neurology

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