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Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures:a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study.

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Trial Profile

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures:a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Eslicarbazepine acetate (Primary) ; Carbamazepine
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Sponsors BIAL - Portela C S.A.

    • Most Recent Events

    • 06 Dec 2022 Results of post hoc analysis(n=288) assessing efficacy and safety/tolerability of eslicarbazepine acetate (ESL) monotherapy vs. controlled-release carbamazepine (CBZ-CR) in PTE vs. non-PTE patients presented at the 76th Annual Meeting of the American Epilepsy Society
    • 22 Apr 2021 Results assessing 10 years of post-marketing surveillance (PMS) safety data of eslicarbazepine acetate collected from randomised clinical trials in adults: BIA-2093-201, -301, -302 -303, -304 and -311, presented at the 73rd Annual Meeting of the American Academy of Neurology.
    • 22 Apr 2021 Results of post hoc analysis from NCT02484001 and NCT01162460; evaluating the lipid changes in adult patients with newly diagnosed focal-onset seizures, presented at the 73rd Annual Meeting of the American Academy of Neurology
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