Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week
Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and
Period 3: a 3-week Taper/Safety Follow-Up Phase.

Inclusion Criteria:

Group 1:

- Subject has a diagnosis of epilepsy with simple partial seizures (motor component)
and/or complex partial seizures with or without secondary generalization

- Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED)
for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior
use of rescue medication (short-term intermittent use) is acceptable

- Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit

- The minimum allowed seizure frequency at any time during the 12 weeks prior to the
Screening Visit is ≥3 partial-onset seizures

Group 2:

- Subject has a diagnosis of epilepsy with simple partial seizures (motor component)
and/or complex partial seizures with or without secondary generalization

- Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens
(concurrently or sequentially)

- Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit

- The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit
is ≥1 partial-onset seizure per 28 days

Exclusion Criteria:

- Previous use of Lacosamide

- History of seizure disorder characterized primarily by isolated auras

- History of primary generalized seizures

- History of status epilepticus within last 12-months

- History of cluster seizures during the 12 week period prior to Visit 1

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

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

- Hypersensitivity to any component of Lacosamide

- History of drug or alcohol abuse

- History of an acute or subacutely progressive Central Nervous System (CNS) disease

- Undergone cranial surgery within the last year prior to study entry

- Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6
months

- Prior or concomitant Vigabatrin use