Health Condition 1: null- Partial Epilepsy
Conditions
Interventions
Intervention1: 800 mg eslicarbazepine: Oral, 800 mg once daily, 2-week titration period and 12-week maintenance period
Intervention2: 1200 mg Eslicarbazepine acetate: Oral, 1200 mg once daily, 2-week
Sponsors
Bial Portela C SA
Pharmanet Clinical Services PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of epilepsy for at least 12 months prior to screening 2. At least 4 partial-onset seizures in the 4 weeks prior to screening 3. Currently taking 1 or 2 AEDs 4. Aged 18+ years
Exclusion criteria
Exclusion criteria: 1 Only simple partial seizures with no motor symptomatology 2 Primarily generalised seizures 3 Known progressive neurological disorders 4 Currently taking oxcarbazepine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Eslicarbazepine acetate once daily at doses of 800 mg and 1200 mg compared with placebo as an adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.Timepoint: 12-week maintenance period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of Eslicarbazepine acetate at once daily doses of 800 mg and 1200 mg compared with placebo, over a 12-week maintenance period preceded by a 2-week titration periodTimepoint: 2-week titration period | — |
Countries
Argentina, Belgium, Cyprus, France, Germany, Greece, India, Poland
Contacts
Public ContactSanjay Kabra
PharmaNet Clinical Services Pvt. Ltd
Outcome results
None listed