Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients

Exclusion Criteria

• •1. A documented history of status epilepticus in the past year.
• •2. Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.
• •3. Diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial epilepsy.
• •4. Meets criteria for history of major depressive or manic episode, according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.
• •5. Any history of suicide intent and/or attempt.
• •6. History or presence of clinically significant, chronic medical condition, especially those contraindicating antiseizure medication, (e.g., any neurological, gastrointestinal, endocrine, cardiovascular, pulmonary, hematological, immunologic, renal, hepatic or metabolic disease) that may affect the safety of the subject in the opinion of the Investigator.
• •7. Use of oxcarbazepine or phenytoin within 10 days prior to first dose of SM.
• •8. Use of felbamate with less than 18 months of continuous exposure prior to screening.
• •9. Frequent need of rescue benzodiazepines (more than once in a 28 day period).
• •10. Use of diuretics or other sodium-lowering medications within seven days prior to first dose of study medication (SM).
• •11. History or presence of clinically significant laboratory, electrocardiogram (ECG), or vital sign abnormalities at screening that may affect the safety of the subject, in the opinion of the Investigator.
• •12. Presence of potential hepatic function impairment as shown by, but not limited to, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal (ULN), or total bilirubin \>1.5 times ULN.
• •13. Presence of suspected impairment of renal function defined by serum creatinine ≥1.5 times ULN.
• •14. History of substance abuse or dependence.
• •15. Females who are pregnant or lactating.
• •16. Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine.
• •17. Use of an investigational drug or device or participation in an investigational study within 30 days prior to the first dose of SM.
• •18. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.