Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

Inclusion criteria

• Diagnosis of treatment resistant partial epilepsy;
• History of epilepsy for at least 2 years;
• Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
• Currently treated on a stable dose of :

• 1 - 3 AED's for at least 12 weeks prior to randomization.
• VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
• Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.

Exclusion criteria

• A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
• Subject has had status epilepticus within past 1 year.
• Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
• Subjects taking felbamate with less than 18 months continuous exposure.
• Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
• No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
• History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
• Subject meets criteria for current major depressive episode (within 6 months).
• Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.