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Focal Epilepsy
Purpose of Study: To evaluate the efficacy, safety, and tolerability of an investigational drug as adjunctive therapy in subjects with Refractory Partial seizures.
Inclusion Criteria:
- Age 16+
- Diagnosed with Epilepsy for at least 1 year with partial seizures
- CT or MRI within past 5 years
- History of inadequate response to at least 1 AED
- Current treatment with 1 to 2 approved antiepileptic drugs and taking a stable dose of the same AED(s) for two months prior to screening
- Vagal nerve stimulator (VNS) is not considered as a concomitant AED
- No seizure-free period for more than 3 weeks
Exclusion Criteria:
- History of alcohol or drug abuse
- Progressive neurological disorder, such as a brain tumor, demyelinating disease, and degenerative CNS disease
- History of status epilepticus, primary generalized seizures, clustering or nonepileptic seizures including psychogenic seizures
- History or current serious or medically unstable systemic disease such as liver disease, renal insufficiency, etc.
- Current or past (within 1 year) major psychotic disorder such as schizophrenia, bipolar disorder, etc.
- Planned epilepsy surgery within the next 6 months
- Currently on ketogenic diet
- History of prior exposure to the study medication
- Received retigabine in previous study
- Treated with felbamate or vigabatrin in the past 6 months
- History of primary generalized seizures
If you qualify, all study related care is provided at no charge including:
- Study visits and study related procedures/tests
- Laboratory tests
- Study drug
- Reimbursement for time/travel expenses
Inclusion/Exclusion Criteria Must Be Met
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