Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as adjunctive therapy for refractory partial seizures in children a doublie-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial.
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 28 Apr 2017
At a glance
- Drugs Eslicarbazepine acetate (Primary)
- Indications Partial epilepsies
- Focus Registrational; Therapeutic Use
- Sponsors Bial
- 28 Apr 2017 Results of population pharmacokinetics modeling of this and one other trial presented at the 69th Annual Meeting of the American Academy of Neurology.
- 18 Dec 2016 According to a Bial media release, based on the data from this study, one phase II study (profile 700204098) and from population PK modelling and exposure-efficacy analyses, the European Commission has extended the marketing authorisation for eslicarbazepine acetate as a once-daily adjunctive treatment for patients aged above six years with partial-onset (focal) seizures with or without secondary generalisation.
- 10 Aug 2015 Planned End Date changed from 1 Oct 2015 to 1 Jun 2017 as reported by ClinicalTrials.gov