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Epilepsy
Purpose of Study: To evaluate the effects of an investigational drug on total partial seizure frequency in adolescent and adult patients with refractory partial onset seizures maintained on a maximum of three stable antiepileptic medications.
Inclusion Criteria:
- Age 12-80 years
- Diagnosed with Epilepsy supported by clinical history, EEG and CT/MRI
- Non-controlled partial seizures despite having been treated with at least two different antiepileptic drugs for at least two years
- Must experience at least 6 seizures during a 56-day baseline with no 21 day seizure free period
- Current treatment with a maximum of three approved antiepileptic drugs and taking a stable dose of the same AED(s) for one month prior to screening
- If using a vagal nerve stimulator (VNS), it must have been implanted for at least six months prior to randomization
Exclusion Criteria:
- Diagnosis of major active psychiatric disease and/or attempted suicide within the previous 10 years
- History of drug and/or alcohol abuse
- Progressive central nervous system (CNS) disease, including degenerative CNS disease and progressive tumors
- Frequent need of rescue benzodiazepines (more than once a month)
- Patients with a known hypersensitivity to rufinamide, triazole derivatives, or to any excipients used in the formulation
If you qualify, all study related care is provided at no charge including:
- Study visits and study related procedures/tests
- Laboratory tests
- Investigational drug
- Possible reimbursement for time and travel
Inclusion/Exclusion Criteria Must Be Met
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