Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

Inclusion criteria

• Male or female patients aged 18-75.
• Able and willing to give written informed consent in accordance with the ICH GCP Guidelines.
• Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum βHCG at screening and negative urine pregnancy test at baseline/during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception as defined here is the oral contraceptive pill, surgical sterilization or hormonal intrauterine device in place for at least 3 months. Women who are less than 2 years post-menopausal are considered to be of childbearing potential.
• Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria.
• Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card.
• Patients should be receiving at least 1 but no more than 2 other AEDs as concomitant medication, and the dosage should be stable for at least 8 weeks before the baseline visit.

Exclusion criteria

• History of status epilepticus within the last 5 years.
• Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed. Note Investigators should consult included SmPC as a guide.
• Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation.
• Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
• Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease.
• Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides.
• Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol.
• Any patient contraindicated for Zonegran treatment as per attached SmPC.
• Any patient who is pregnant and/or lactating.