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.
Phase of Trial: Phase III
Latest Information Update: 06 Sep 2017
At a glance
- Drugs Eslicarbazepine acetate (Primary) ; Carbamazepine
- Indications Partial epilepsies
- Focus Registrational; Therapeutic Use
- Sponsors Bial
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History