A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures.

Condition(s) targeted: Epilepsy; Seizures

Intervention: topiramate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Cilag Pharmaceutica S.A.C.I., Greece

Official(s) and/or principal investigator(s):
Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial, Study Director, Affiliation: Janssen Cilag Pharmaceutica S.A.C.I., Greece

The purpose of this study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.

Official title: An Open-Label Observation Study Of Topiramate Administration As Adjuvant Therapy For Focal Epilepsy, Lennox-Gastaut Syndrome Epileptic Seizures And Generalized Tonoclonic Seizures In Adults And Children Aged 2 Years And Older.

Study design: Prospective

Detailed description: 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 (focal epilepsy, LENNOX-GASTAUT syndrome epileptic seizures and generalized tonic-clonic seizures) in adults and in children aged 2 years and older. 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 daily clinical practice. 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.

Individualization of the treatment should begin with administration of the drug in the evening, from 25 mg for one week. Subsequently, every week or every two weeks, the dose should be increased by 25-50 mg/day and be taken in two divided doses. Study duration: 6 Months

Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Non-premenopausal female patients using a medically acceptable contraceptive method as

discussed with their doctor

- History of medical records of frequency and the type of seizures during the period

prior to inclusion in the study

- 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

Starting date: November 2003
Ending date: June 2005
Last updated: October 19, 2007