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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.
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