A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Life Science; SK Life Science, Inc.

Criteria

Inclusion Criteria:

• Diagnosis of partial onset seizures

• had a neuroimaging procedure (computed tomography [CT] or magnetic resonance imaging [MRI] within the past 5 years that excluded a progressive neurologic disorder

• History of inadequate response to at least 1 antiepileptic drug

• Current treatment with at least 1 and up to 3 antiepileptic drugs. To be eligible for the double-blind treatment phase of study CARISEPY3013, patients must: have at least 6 partial onset seizures during the 56-day baseline period

• Have not had > = 100 partial onset seizures per 28 days in the baseline period

• And no seizure-free period of more than 3 weeks during the baseline period.

Exclusion Criteria:

• History of status epilepticus or epilepsia partialis continua in the 6 months before study entry

• Have a generalized epileptic syndrome

• have a diagnosis of Lennox-Gastaut Syndrome

• Currently experiencing seizures that cannot be counted accurately

• have experienced rates of > = 100 partial onset seizures in any monthly period in the 6 months before study entry

• Have a history of any current or past nonepileptic seizures, including psychogenic seizures

• History of or current serious or medically unstable systemic disease

• evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome, or significant shortening or lengthening of the QTc interval of the electrocardiogram

• progressive neurologic disorder, such as a brain tumor, demyelinating disease, and degenerative CNS disease, or active CNS infection

• current or past (within the past year) major psychotic disorder

• History of suicidal or homicidal ideation within the past 2 years, or an episode of suicide attempt or homicide at any time in the past.