Trial Information

Summary: Trial to Assess the Safety of a Single Dose of iv Lacosamide Followed by Twice Daily Oral Lacosamide in Patients With Partial-Onset Seizures.

A Multicenter, Open-Label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-Onset Seizures

Inclusion Criteria:

• Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
• stable dose regimen of 1 to 2 marketed AEDs for 28 days prior to screening and duration of trial
• acceptable candidate for venipuncture and 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
• nonepileptic events, including psychogenic seizures that could be confused with seizures
• use of neuroleptics, MOA 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.

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Trial listings updated: October 27, 2008 at 2:24:15 PM