Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

This multicenter, open-label trial examined safety and tolerability of rapid initiation of
adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance
treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive
25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400
mg) administered as a single 15-minute intravenous (iv) loading dose followed by the
equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose
12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to
provide safety data on a total of 50 subjects at the highest well-tolerated dose.

Inclusion Criteria:

- Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures

- Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days
prior to screening and duration of trial

- Acceptable candidate for venipuncture and intravenous (iv) infusion

- At least 1 partial seizure with motor component per 90 days

- Maximum allowed seizure frequency during 28 days prior to screening is 40 partial
seizures of any type

Exclusion Criteria:

- Previous use of lacosamide

- History of primary generalized seizures

- History of status epilepticus within last 12 months

- History of cluster seizures during 8 week period prior to screening

- Non-epileptic events, including psychogenic seizures that could be confused with
seizures

- Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic
analgesics within 28 days prior to screening

- Received any rescue benzodiazepines more than once during the 28 days prior to
screening

- Concomitant treatment of felbamate or previous felbamate therapy within last 6 months

- Prior or concomitant vigabatrin use