Efficacy and Safety of Eslicarbazepine Acetate as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures

Epilepsy Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures.

Clinical Trial Description

Epilepsy affects more than 50 million adults and children worldwide. Prevalence estimates in the total population vary from 4 to 8 per 1000 subjects. Anti-epileptic drugs (AEDs) are the major intervention and approximately 60% of newly diagnosed patients are seizure free on a single AED, but about 40% are not satisfactorily controlled and 25% suffer from significant adverse events (AEs). This lack of seizure control and unsatisfactory tolerability means there is still a need for new, effective AEDs that can be used as monotherapy.

Given the efficacy of ESL in controlling partial onset seizures, the good tolerability and the convenience of QD dosing instead of twice daily (BID) dosing, ESL could offer a beneficial alternative as a first-line therapy in patients newly diagnosed with epilepsy experiencing partial-onset seizures. This study aims to demonstrate the efficacy and safety of ESL as a monotherapy treatment for this patient population proving non-inferiority to a standard therapy, Carbamazepine controlled release (CBZ-CR). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Seizures

• NCT number: NCT01162460
• Study type: Interventional
• Source: Bial - Portela C S.A.
• Status: Completed
• Phase: Phase 3
• Start date: December 2010
• Completion date: September 2016