Efficacy and Safety of Eslicarbazepine Acetate as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures
- Registration Number
- NCT01162460
- Lead Sponsor
- Bial - Portela C S.A.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 815
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carbamazepine controlled release Eslicarbazepine acetate (BIA 2-093) - Eslicarbazepine acetate Eslicarbazepine acetate (BIA 2-093) -
- Primary Outcome Measures
Name Time Method 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. 26 weeks
- Secondary Outcome Measures
Name Time Method QOLIE-31 and Bond-Lader VAS 26 weeks; up to 183 weeks Changes in quality of life assessed using the QOLIE-31 (Overall score, subscores covering emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects and assessment of overall health).
Time to treatment failure at the first evaluated dose 26 weeks Time to treatment failure at the first evaluated dose, where time to treatment failure is defined as the time of the first occurrence of 1 of the following:
* Seizure
* Withdrawal of IMP due to AEs.
* Withdrawal of IMP due to lack of efficacy.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 subjects 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 Treatment retention time at the last evaluated dose 26 weeks Treatment retention time at the last evaluated dose, where treatment retention time is defined as the time of the first occurrence of one of the following:
* Withdrawal of IMP due to AEs.
* Withdrawal of IMP due to lack of efficacy.seizure freedom 26 weeks Dose level at which subjects reached 26-week seizure freedom.
Adverse Event monitoring up to 183 weeks Incidence of AEs, SAEs, withdrawals, out-of-range laboratory values, abnormal 12-lead ECG and physical examination findings.
Trial Locations
- Locations (1)
BIAL - Portela & Cª, S.A.
🇵🇹S. Mamede do Coronado, Portugal