Efficacy and safety of BIA 2-093 as adjunctive therapy for refractory partial seizures in a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial
- Conditions
- About 40% of the patients suffering from epilepsy are not satisfactorily controlled and 25% suffer from significant adverse events. This lack of seizure control means that combination therapy is often recommended, but a sizeable proportion of patients continue to have regular seizures. Therefore, there is still a need for new, effective AEDs, particularly those that can be used safely as adjuncts to standard therapy.
- Registration Number
- EUCTR2004-000766-12-AT
- Lead Sponsor
- BIAL Portela & Companhia, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 460
documented diagnosis of simple or complex partial seizures with or withou secondary generalisation since at least 12 months, at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs in a stable dose regimen during at least 2 months prior to screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
only simple partial seizures with no motor symptomatology, primarily generalised epilepsy, seizures of psychogenic origin, currently on or with exposure to felbamate or oxcarbazepine more within on month of screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method