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: 28 Jun 2017

At a glance

  • Drugs Eslicarbazepine acetate (Primary) ; Carbamazepine
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Sponsors Bial
  • Most Recent Events

    • 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.
    • 27 Mar 2017 Results published in an Eisai media release.
    • 27 Mar 2017 According to an Eisai media release, eslicarbazepine acetate (Zebinix) has received a positive opinion for use as a once-daily monotherapy to treat adults with newly-diagnosed focal onset epilepsy from The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP). The CHMP based its decision on positive results from this trial.
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