Status:
COMPLETED
A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Epilepsy, Partial, Motor
Epilepsy, Complex Partial
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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.
Detailed Description
According to the World Health Organization (WHO), epilepsy afflicts more than 50 million people worldwide. Older antiepileptic drugs are still commonly used, despite a diverse range of side effects. N...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT00740623
Start Date
January 1 2009
End Date
April 1 2010
Last Update
January 24 2013
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