A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

Exclusion Criteria

• •1. Subjects have a history of clinical investigations, including EEG data, that are suggestive of idiopathic generalised epilepsy as defined by the International League Against Epilepsy (ILAE).
• •2. Subjects with a history of absence, myoclonic, clonic, tonic, or atonic seizures.
• •3. Subjects have a history of status epilepticus, and/or non-epileptic seizures (e.g., metabolic, pseudo-seizures).
• •4. Subjects have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation-related seizures.
• •5. Subjects have progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination, or tumour).
• •6. Subjects have a history of a significant or currently uncontrolled disease that will interfere with the conduct of this study or the assessment of safety and efficacy of the study drug.
• •7. Subjects have been previously treated with carbamazepine or zonisamide.
• •8. Subjects have received an investigational drug or device in the three months prior to the Screening Visit.
• •9. Subjects have a known hypersensitivity to sulfonamides, dibenzazepine derivatives, or tricyclic antidepressants.
• •10. Subjects have a history of bone marrow depression, low platelet count or other blood dyscrasia.
• •11. Subjects have a history of acute intermittent porphyria.
• •12. Subjects have a history of renal disorder (serum creatinine level of \> 135 ìmol / l (1.5 mg/dL at the Screening Visit), hepatic disorder or clinically significant abnormal liver function tests; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>2 times the upper normal limit.
• •13. Subjects have a body weight of less than 40 kg.
• •14. Subjects have a history of progressive malignancy within the previous 5 years (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
• •15. Subjects have a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse; chronic treatment with benzodiazepines or barbiturates.
• •16. Subjects are currently taking carbonic anhydrase inhibitors.
• •17. Subjects have a history of pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory or electro-cardiographic abnormalities, or uncontrolled hypertension.
• •18. Subjects are currently taking mono-amine oxidase inhibitors (MAOIs) or any other excluded medications.