Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
Phase 3
Completed
- Conditions
- Health Condition 1: null- Partial Epilepsy
- Registration Number
- CTRI/2011/04/001686
- Lead Sponsor
- Bial Portela C SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 615
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
1Only simple partial seizures with no motor
symptomatology
2Primarily generalised seizures
3Known progressive neurological disorders
4Currently taking oxcarbazepine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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