Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal
relationship with the administration of antiepileptic drugs has not been established. The
most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the
occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients
with only GTCS were enrolled in the conversion to monotherapy study. In this study, two
patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients
with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from
this study.

Inclusion Criteria:

- Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and
or Complex Partial Seizures (with or without secondary generalization)

- Must be experiencing 2 to 40 seizures per 28-day period

- Stable dose of 1 or 2 marketed antiepileptic drugs

- Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum
recommended maintenance dose per USA product label at screening

Exclusion Criteria:

- Subject has a history of primary generalized or unclassified seizures

- Seizure disorder primarily characterized by isolated auras

- History of status epilepticus

- Seizures that are uncountable due to clustering

- Has greater than 5 seizures/day

- Subjects taking Benzodiazepines, Phenobarbital or Primidone

- Subject has Vagus Nerve Stimulation (VNS)

- Significant medical or psychiatric condition

- History of alcohol or drug abuse

- History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997