Focal Epilepsy

Drug under Investigation:  E2007

Purpose of Study:  To determine the maximal tolerated dose (MTD) of E2007 in patients with refractory partial-onset seizures (including secondarily generalized seizures), and to evaluate the safety, efficacy, concentration-efficacy relationship, and pharmacokinetics of E2007, and the effects of E2007 on the Profile of Mood States (POMS) test.

Inclusion Criteria:

• Age 18-70 years
• Weigh 40kg (88 lbs) or more
• Have diagnosis of epilepsy with partial-onset seizures with or without secondarily generalized seizures
• Have uncontrolled partial seizures despite having been treated with at least three different AEDs (given concurrently or sequentially) for at least 2 years
• Have averaged at least 4 partial seizures per month, with no 21-day seizure-free period during the 2 months preceding enrollment
• Are currently been treated with one or a maximum of two licensed AEDs and are known to take medication(s) as directed
• Are on a stable dose(s) of the same AED(s) for the 2 months prior to screening

Exclusion Criteria:

• Have participated in a study involving administration of an investigational compound within one month of screening
• Presence of non-motor simple partial seizures only
• Presence of primary generalized epilepsies or seizures
• History of status epilepticus in the past year
• Presence of non-motor simple partial seizures only
• Presence of primary generalized epilepsies or seizures
• Evidence of of significant active hepatic or hematological disease
• Clinically significant ECG abnormality
• Presence of major active psychiatric disease
• Presence of a progressive central nervous system disease
• Have a history of psychogenic seizures
• Have a history of drug abuse and/or positive finding on a urinary drug screening
• Have a history of alcohol abuse in the past 2 years, and/or positive finding on urinary drug screen
• Had had multiple drug allergies
• Allergy to lactose
• Concomitant use of felbamate or use of felbamate within 2 months prior to screening
• Concomitant use of vigabatrin
• Concomitant use or use within the previous 4 weeks prior to screening of neuroleptics, MAO inhibitors, barbiturates, benzodiazepines, and narcotic analgesics

Inclusion/Exclusion Criteria Must Be Met