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
Overview
- Phase
- Phase 3
- Intervention
- Eslicarbazepine acetate (BIA 2-093)
- Conditions
- Epilepsy
- Sponsor
- Bial - Portela C S.A.
- Enrollment
- 815
- Locations
- 1
- Primary Endpoint
- The primary efficacy variable will be the proportion of subjects in the PP set who are seizure free for the entire 26-week Evaluation Period at the last received dose level.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Detailed 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Carbamazepine controlled release
Intervention: Eslicarbazepine acetate (BIA 2-093)
Eslicarbazepine acetate
Intervention: Eslicarbazepine acetate (BIA 2-093)
Outcomes
Primary Outcomes
The primary efficacy variable will be the proportion of subjects in the PP set who are seizure free for the entire 26-week Evaluation Period at the last received dose level.
Time Frame: 26 weeks
Secondary Outcomes
- QOLIE-31 and Bond-Lader VAS(26 weeks; up to 183 weeks)
- Time to treatment failure at the first evaluated dose(26 weeks)
- Proportion of subjects in the ITT set without a seizure during the 26-week Evaluation Period at the last evaluated dose.(26 weeks)
- Proportion of seizure-free subjects during 1 year of treatment at the last evaluated dose, where the end of the 1-year period is defined as the same start date as for the 26-week evaluation +365 days.(52 weeks)
- Time to first seizure at the last evaluated dose set.(up to 183 weeks)
- Proportion of subjects without a seizure during the 26-week Evaluation Period at the last evaluated dose.(26 weeks)
- Treatment retention time at the last evaluated dose(26 weeks)
- seizure freedom(26 weeks)
- Adverse Event monitoring(up to 183 weeks)