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.
|Study Design:||Time Perspective: Prospective|
|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|
- Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older. [ Time Frame: At visit 3-8 ] [ Designated as safety issue: No ]
- Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs. [ Time Frame: Visits:3-8 ] [ Designated as safety issue: No ]
- Evaluation of efficacy will be performed with the aid of descriptive statistics. [ Time Frame: Visits:3-8 ] [ Designated as safety issue: No ]
- Overall assessments of the improvement in the seriousness of seizures will be performed. [ Time Frame: Visits:3-8 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Study Completion Date:||June 2005|
Individualization of the treatment should begin from 25 mg for 1 week.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297349
|Study Director:||Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial||Janssen-Cilag Pharmaceutica S.A.C.I.|