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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2018

At a glance

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

    • 27 Jun 2018 According to a Sunovion Pharmaceuticals media release, based on results from this trial, the Health Canada (July 2018) has approved eslicarbazepine acetate (Zebinix) for use as a once daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy.
    • 25 Jan 2018 Results assessing safety and efficacy published in the Epilepsia
    • 22 May 2017 According to an Eisai Co. Ltd. media release, the European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as a once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy based on results from this trial.
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