Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures
The objective of this historical-controlled trial is to demonstrate the efficacy and safety
 of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are
 withdrawn from 1 to 2 marketed antiepileptic drugs.
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 with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from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