Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure

A Multicenter, Open Label Study to Evaluate the Tolerability, Safety and Efficacy of Lacosamide (200mg - 400mg/Day) as add-on Therapy for Patients With Partial Onset Epilepsy Using a Flexible Dose-escalation Schedule and Individualized Maintenance Doses

To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.

Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility

Inclusion Criteria:

• Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization
• Currently taking 1 to 3 concomitant marketed antiepileptic drugs
• 18 years and older at study entry

Exclusion Criteria:

• Previous use of lacosamide
• Hypersensitivity to any component of lacosamide
• Patients with partial onset seizures not clearly identifiable
• History of generalized epilepsy
• History of status epilepticus within last 12 months
• Uncountable seizures due to clustering within last 12 weeks
• Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures
• History of drug or alcohol abuse
• History of suicide attempt
• Progressive cerebral disease
• Concomitant treatment of felbamate
• Prior or concomitant vigabatrin use
• Under legal protection