An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy
Epilepsy, Epilepsies, Partial
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Refractory partial epilepsy, seizure disorder, antiepileptic drugs
Eligibility Criteria
Inclusion Criteria: In order to enter the open label extension, the patient must have completed Study 333369EPY-2001. Exclusion Criteria: Patients who have seizures that cannot be quantitated accurately patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months patients with a history of drug or alcohol abuse within the past 2 years patients currently taking felbamate, vigabatrin, or tricyclic antidepressants and female patients who are pregnant or nursing.
Sites / Locations
Arms of the Study
Arm 1
Experimental
001
RWJ 333369: Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor