Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures

INCLUSION CRITERIA

1. Male and female patients between 12 and 80 years of age, inclusive.
2. Diagnosis of epilepsy with partial-onset seizures with or without secondarilygeneralized seizures according with the International League Against EpilepsyClassification of Epileptic Seizures (1981). Diagnosis should have been established byclinical history, electroencephalogram (EEG) and computed tomography/magneticresonance imaging (CT/MRI) of the brain performed within the last 10 years andconsistent with localization-related epilepsy.
3. Non-controlled partial seizures despite having been treated with at least twodifferent antiepileptic drugs (given concurrently or sequentially) for at least twoyears.
4. Patient willing to participate and written consent signed by patient or legal guardianprior to entering the study or undergoing any study procedures. If the written consentis provided by a legal guardian because the patient is unable to do so, assent of thepatient must also be obtained.
5. Reliability and willingness of patients to make themselves available for the studyperiod, and ability to record seizures and report adverse events themselves or have acaregiver who can record seizures and report adverse events.
6. Female patients of non-childbearing potential by reason of surgery, radiation, ormenopause (at least one year post onset); or of childbearing potential using twoapproved methods of contraception (such as an intrauterine device [IUD], implant, oralcontraceptive, or barrier method plus spermicide). Use of a low-dose estrogen oralcontraceptive ("minipill") alone will not be permitted. Female patients ofchildbearing potential must have a confirmed negative serum pregnancy test atscreening and a negative urine pregnancy test prior to randomization, and agree tocontinue to use two approved methods of contraception through the follow-up visit (Visit 8) or for 30 days after their final dose of study medication, whichever islonger.
7. At least six seizures during the prospective Baseline Phase (56 days) with no 21-dayseizure-free periods. Simple partial seizures without motor signs will not be includedin determining this criterion.
8. Current treatment with a maximum of three approved antiepileptic drugs, and noevidence of non-compliance with ongoing AED therapy.
9. Stable dose(s) of the same AED(s) for one month prior to screening.
10. If using a vagal nerve stimulator, it must have been implanted for at least six monthsprior to randomization. Stimulator parameters may not be changed for at least onemonth prior to screening or thereafter during the study. Magnet use will be allowed,but must be documented throughout the study. A vagal nerve stimulator will not becounted as an AED for the purpose of inclusion into the trial.

EXCLUSION CRITERIA:

1. Participation in a study involving administration of an investigational compoundwithin one month of Visit 1 (Screening), or within five half-lives of the previousinvestigational compound, whichever is longer; or any prior exposure to rufinamide.
2. Presence of non-motor simple partial seizures only.
3. Presence of generalized epilepsies or seizures, such as absences, myoclonicepilepsies, Lennox-Gastaut syndrome.
4. History of status epilepticus in the past year or seizure clusters where individualseizures cannot be counted.
5. Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal,hepatic, hematologic or renal disease, etc.) that in the opinion of the Investigatorcould affect the patient's safety or trial conduct.
6. Clinically significant ECG abnormality.
7. Patients with a diagnosis of major active psychiatric disease will be excluded fromthe study. However, those patients who are only taking a stable dose of either aselective serotonin reuptake inhibitor (SSRI) antidepressant drug or a serotonin andnorepinephrine reuptake inhibitor (SNRI) antidepressant drug for a diagnoseddepressive disorder can be included as long as they have been on the SSRI or SNRI fora period of two months or longer before randomization. Other antidepressantmedications will not be allowed.
8. Progressive central nervous system (CNS) disease, including degenerative CNS diseasesand progressive tumors.
9. Occurrence of psychogenic seizures in the previous year.
10. History of drug abuse and/or positive finding on urinary drug screening, other thanprescribed medication
11. History of alcohol abuse in the past two years.
12. History of suicide attempt within the previous 10 years.
13. Multiple drug allergies (dermatological, hematological or organ toxicity) or more thanone severe drug reaction(s).
14. Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
15. Frequent need of rescue benzodiazepines (more than once a month).
16. Patients with a known hypersensitivity to rufinamide, triazole derivatives, or to anyexcipients used in the formulation.
17. Concomitant use of vigabatrin. Patients who took vigabatrin in the past must be offvigabatrin for at least five months prior to Visit 1 and must not have evidence of aclinically significant abnormality in a visual perimetry test.
18. All Patients with a diagnosis of Congenital Short QT Syndrome. Patients with a familyhistory of Congenital Short QT Syndrome may be excluded on the basis of theInvestigator's clinical judgment.