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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Determine the Efficacy and Safety of Retigabine (1200 mg/day) Used as Adjunctive Therapy in Refractory Epilepsy Patients with Partial-onset Seizures
reatment Study for Epilepsy
Principal Investigator:   Jeffrey Cohen, MD, PhD
Co-Investigator:   Kyusang Lee, MD
Time frame of study:   Eight months
Number of participants needed:   6
Location of Study:   Beth Israel Medical Center
First Avenue and 16th Street
New York, NY 10003
Contact Name, Number & Email:   General Info at (212) 844-6111


Summary:
This is a multi-center study to evaluate the efficacy and safety of a new antiepileptic medication, retigabine, compared with placebo, in patients with seizures and epilepsy whose seizures have not been controlled despite taking one to three other antiepileptic medications. This study evaluates retigabine as add-on therapy (subjects continue to take there usual antiepileptic medications). This study is being conducted at multiple hospitals in the US and in other countries.

Criteria for Participation:
Subjects may be aged 18-75, and must have at least four partial seizures per month. They may be taking up to three other antiseizure medications. Women participants must not be pregnant.

Duration:
The expected duration of study participation is 32 weeks. Subjects will have the option of continuing retigabine in an open-label study which follows the end of this trial.

Benefits/Compensation:
The costs of retigabine, study visits, and all tests related to the study are provided at no charge. There is no payment for participation in this study. Travel to and from the study visits will be reimbursed. While it is possible that your seizures may improve with retigabine, this cannot be guaranteed.