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Efficacy and Safety of BIA 2-093 as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

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Trial Profile

Efficacy and Safety of BIA 2-093 as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2025

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At a glance

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

Most Recent Events

  • 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.
  • 08 Dec 2020 Results of exploratory post hoc analysis evaluating safety and tolerability of eslicarbazepine acetate (ESL) as adjuvant therapy to one concomitant AED presented at the 74th Annual Meeting of the American Epilepsy Society
  • 01 May 2020 Results of post hoc pooled analysis (BIA2093-301, 302 and 304) evaluating the occurrence of psychiatric adverse events (AEs) in clinical trials of adjunctive eslicarbazepine acetate (ESL) in adults with focal seizures, according to psychiatric history and current symptom status presented at the 72nd Annual Meeting of the American Academy of Neurology

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