A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
The purpose of this observational study is to evaluate the safety of topiramate when used in
 combination with other medications for seizures in adults and children.
Topiramate is a medication that is approved for the treatment of seizures. In accordance with
 International guidelines, studies are conducted after a drug is marketed to continue to
 evaluate and expand the knowledge regarding its safety. This is an open-label, multi-center
 observational safety study to collect safety information for oral topiramate given in
 addition to other medications for 3 types of seizures in adults and in children aged 2 years
 and older.The 3 seizures types are focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures
 and generalized tonic-clonic seizures. Patients whose previous treatment for seizures (one or
 more antiepileptic drugs) has been judged by their physician to be non-satisfactory will
 receive 6 months of treatment with topiramate in addition to other antiepileptic medication
 as prescribed by their physician. Topiramate will be given at low doses initially and
 gradually increased as necessary to control seizure activity in accordance with Summary of
 Product Characteristics (SmPC). Patients will be asked to keep a diary of adverse events and
 seizure activity. Safety evaluations (incidence of adverse events, physical examinations,
 vital signs and laboratory tests) will be performed throughout the study per investigators
 usual standard of care. At the end of the study, the treating physician may continue
 treatment with topiramate and other medication as appropriate. The study hypothesis is that
 topiramate given in combination with other antiepileptic medications will be effective in
 achieving and maintaining control of seizure activity and is well-tolerated. 225 adult
 patients and children aged 2 years or older will be enrolled in the study. Study participants
 should demonstrate focal epilepsy or epileptic seizures of the LENNOX-GASTAUT syndrome or
 generalized tonoclonic seizures, who have undergone treatment with one or more antiepileptic
 drugs and whose treatment should be judged by the investigator as non-satisfactory.
 Observational study - No investigational drug administered.
Inclusion Criteria:

 -  Non-premenopausal female patients using a medically acceptable contraceptive method as
 discussed with their doctor

 -  History of the type of seizure during the period prior to inclusion in the study and
 sufficient medical records to document this. Prior treatment until inclusion in the
 study with one or more antiepileptic drug treatment judged non-satisfactory by the
 investigator

 Exclusion Criteria:

 -  Patients not suffering from epilepsy, whose seizures are due to other causes including
 disease, exposure to harmful substances, active infection or tumor

 -  Patients with a history of generalized status epilepticus (prolonged seizures) within
 the last three months

 -  Patients with progressive brain tumor or other progressive or degenerative disorders

 -  Patients with a history (within the previous six months) of mental or emotional
 disorders requiring shock treatment or major sedation, monoamine oxidase (MAO)
 inhibitors or medications which affect the central nervous system

 -  Patients with any medical or social condition that may affect their ability to take
 part in study or the safety of the study

 -  Patients who cannot take the drug or fill in the diary, either alone or with help. If
 help is needed, it should be permanently available throughout the study