eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

Inclusion Criteria:

- Subject is male or female, at least 18 years of age

- Subject has a diagnosis of epilepsy with partial-onset seizures according to the
International Classification of Epileptic Seizures (1981)

- Subject is taking levetiracetam (LEV) in combination with 1 sodium channel blocking
antiepileptic drug (defined as carbamazepine, lamotrigine, oxcarbazepine, phenytoin,
or eslicarbazepine) as adjunctive treatment for epilepsy

- The minimum required seizure frequency during the 8-week Retrospective Seizure
Baseline is on average ≥ 2 partial-onset seizures per 28 days with at least 1 seizure
per 4 week period within the 8-week Retrospective Seizure Baseline. Additionally,
subjects must experience at least 1 seizure during the 4-week Prospective Seizure
Baseline

- Subject has been maintained on a stable dose of LEV and a sodium channel blocking
antiepileptic drug (SCB-AED) for at least 4 weeks prior to the Screening Visit (Visit
1) and during the 4-week Prospective Seizure Baseline

- The minimum required seizure frequency during the 8-week Retrospective Seizure
Baseline is on average ≥ 2 partial-onset seizures per 28 days (based on investigator
assessment of subject report) with at least 1 seizure per 4 week period within the
8-week Retrospective Seizure Baseline

- Subject has been maintained on a stable dose of levetiracetam (LEV) and a sodium
channel blocking antiepileptic drug (SCB-AED) for at least 4 weeks prior to the
Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline, with or
without additional concurrent stable vagal nerve stimulation (VNS). The VNS must have
been in place for at least 6 months prior to the Screening Visit (Visit 1) with
constant settings for at least 4-weeks prior to the Screening Visit (Visit 1) and
throughout the duration of the study

Exclusion Criteria:

- Previous use of lacosamide

- History of alcohol or drug abuse

- History of seizure disorder characterized primarily by isolated auras

- History of primary generalized seizures

- History of status epilepticus within the 12-months

- History of clustering seizures

- Nonepileptic events, including pseudoseizures that could be confused with seizures

- History of any medical or psychiatric condition that, in the opinion of the
investigator, could jeopardize the subject's health or would compromise the subject's
ability to participate in this study

- Lifetime history of suicide attempt, or suicidal ideation in the past 6 months

- Hypersensitivity to any component of lacosamide (LCM)

- History of acute or sub-acute progressive central nervous system disease

- History of severe anaphylactic reaction or serious blood dyscrasias

- Impaired renal function (ie, Creatinine Clearance (CLcr) is lower than 30 mL/min) at
Visit 1

- History of sick sinus syndrome without a pacemaker, or atrioventricular (AV) block, or
subject has any other clinically significant electrocardiogram (ECG) abnormalities

- History sodium channelopathy, such as Brugada syndrome

- History of myocardial infarction in the last 3 months