Trial Information

Summary: Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-Onset Seizures

A Historical-Controlled, Multicenter, Double-Blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/Day Monotherapy in Subjects With Partial-Onset Seizures

The objective of this historical-controlled trial is to assess the efficacy and safety of lacosamide monotherapy in subjects with partial-onset seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

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 AED must be less than or equal to 50% of the minimum effective dose per US 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 VNS
• Significant medical or psychiatric condition
• History of alcohol or drug abuse
• History of felbamate, vigabatrin, or ethosuximide use

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Trial listings updated: June 1, 2008 at 6:43:24 AM