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.
Conditions
Interventions
Product Name: -
Product Code: BIA 2-093
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
BIAL Portela & Companhia, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluating efficacy of BIA 2-093 once daily at doses of 400, 800 and 1200 mg compared with placebo ad adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period;Secondary Objective: (1) To evaluate the safety and tolerability of BIA 2-093 at once-daily doses of 400 mg, 800 mg and 1200 mg in comparison to placebo, over a 12-week maintenance period preceded by a 2-week titration period and followed by a 4-week tapering-off period. (2) To evaluate the safety and tolerability of BIA 2-093 at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. (3) To assess the maintenance of therapeutic effects of BIA 2-093 over a 12-week maintenance period preceded by a 2-week titration period and followed by a 4-week tapering-off period and over a 1-year open-label period. (4) To assess the drug-drug pharmacokinetic interactions between BIA 2-093 and concomitant anti-epileptic drugs over the double-blind and open-label parts of the study. (5) To assess the health-related quality-of-life and depressive symptoms over the double-blind and open-label parts of the study;Primary end point(s): Seizure frequency over the 12-week maintenance period. Seizure frequency will be standardised to a “frequency per 4 weeks” basis | — |
Countries
Austria
Outcome results
None listed