Efficacy and safety of Eslicarbazepine Acetate (BIA 2-093) as single therapy for patients with newly diagnosed partial-onset seizures - ESL extension study
Phase 3
Recruiting
- Conditions
- EpilepsyG40.0G40.1G40.2
- Registration Number
- RBR-93gkd4
- Lead Sponsor
- Instituto de Neurologia de Curitiba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Participation in the preceding double-blind study and still ongoing at the time of unblinding; informed consent signature; cooperation and willingness to complete all aspects of the study.
Exclusion Criteria
Exclusion from the double-blind study; clinical evaluation of suicidal risk; occurrence of an adverse event; events of alcohol, drug, or medication abuse; relevant clinical laboratory abnormalities; pregnancy or lactating.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to treatment failure for subjects already treated with ESL during the double-blind study, through Kaplan-Meier method, for survival probability estimation.<br>
- Secondary Outcome Measures
Name Time Method Treatment retention time at the last evaluated dose during open-label treatment, through descriptive statistics; <br>Time to withdrawal for any reason at the last evaluated dose, through descriptive statistics;<br>Changes in quality of life assessed using the QOLIE-31, through descriptive statistics;<br>Changes in overall treatment satisfaction, through descriptive statistics.