Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Condition: Refractory Partial Onset Seizures
MeSH terms: Seizures
Intervention: Rufinamide
Intervention description: Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Intervention MeSH terms: Rufinamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 286.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Refractory Partial Onset Seizures, epilepsy

Summary:

      This was an open-label extension study in adolescent and adult (between 12 and 80 years old)
      participants who had completed their participation in Study E2080-A001-301. The main
      objective of this study was to evaluate the safety and efficacy of long-term administration
      of rufinamide for the control of epileptic seizures in participants who had refractory
      partial seizures despite treatment with a maximum of three approved antiepileptic drugs
      (AEDs).
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Completion of Study E2080-A001-301 and full compliance with the inclusion and
             exclusion criteria for that study (excluding criteria that are related to seizure
             occurrences).

          2. Patient willing to participate and written consent signed by patient or legal guardian
             provided prior to entering this study or undergoing any study procedures. In addition,
             if the patient is unable to provide written informed consent and it is provided by a
             legal guardian, assent of the patient (if the patient is able) must also be obtained.

          3. Female patients of non-childbearing potential by reason of surgery, radiation, or
             menopause (at least one year post onset); female patients of childbearing potential
             who are using at least two approved methods of contraception (such as an intrauterine
             device [IUD], implant, oral contraceptive, or barrier method plus spermicide). Use of
             a low-dose estrogen oral contraceptive alone will not be permitted. Female patients of
             childbearing potential must agree to continue to use two approved methods of
             contraception through the follow-up visit or for 30 days after their final dose of
             study medication, whichever is longer.

        EXCLUSION CRITERIA:

          1. Discontinuation from Study E2080-A001-301 for any reason, before the termination of
             the study.

          2. Evidence of non-compliance with study drug or ongoing AED dosing during Study
             E2080-A001-301.

          3. Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal,
             hepatic (e.g., ALT > 3x ULN), hematologic, renal, or psychiatric disease, etc.) that
             in the opinion of the Investigator could affect the patient's safety or trial conduct.

          4. Progressive central nervous system (CNS) disease, including degenerative CNS diseases
             and progressive tumors.

          5. History of alcohol abuse in the past 2 years.

          6. History of suicide attempt within the previous 10 years.

          7. Multiple drug allergies (dematological, heatological or organ toxicity) or more than
             one severe drug reaction.

          8. Concomitant use of felbamate or vigabatrin.

          9. Pregnancy.

         10. Clinically significant ECG abnormality.

         11. All patients with a diagnosis of Congenital Short QT Syndrome. Patients with a family
             history of Congenital Short QT Syndrome may be excluded on the basis of the
             Investigator's clinical judgement.

         12. Presence of major active psychiatric disorder. Patients will be allowed who are taking
             a stable dose of selective serotonin reuptake inhibitor (SSRI) or mixed serotonin and
             norepinephrine uptake inhibitor antidepressant.