Epilepsy, Complex Partial Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures.
Verified date | January 2013 |
Source | SK Life Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 547 |
Est. completion date | April 2010 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SK Life Science |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary efficacy endpoints are percent reduction in partial onset seizure frequency in the US and the rest of the world (excluding Europe, Australia, New Zealand, S Africa), and responder rate for Europe, Australia, New Zealand, S Africa | from baseline relative to the entire double-blind treatment phase (14 weeks) | No | |
Secondary | Secondary endpoints are percent reduction in partial onset seizure frequency for EuropeAustraliaNew Zealand S Africa, percent reduction in secondarily generalized seizure and time to onset of treatment effect on partial onset seizure frequency reduction | from baseline relative to the entire double-blind treatment phase (14 weeks) | No |
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