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Sponsored by: |
Janssen Cilag Pharmaceutica S.A.C.I., Greece |
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Information provided by: | Janssen Cilag Pharmaceutica S.A.C.I., Greece |
ClinicalTrials.gov Identifier: | NCT00297349 |
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.
Condition | Intervention | Phase |
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Epilepsy Seizures |
Drug: topiramate |
Phase IV |
Study Type: | Observational |
Study Design: | 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. |
Estimated Enrollment: | 165 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | June 2005 |
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
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003472 |
Study First Received: | February 24, 2006 |
Last Updated: | October 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00297349 History of Changes |
Health Authority: | Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines |
Lennox-Gastaut Syndrome Seizures Focal Epilepsy Epilepsy in Children |
Topiramate Epilepsy Tonic-clonic |
Epilepsies, Partial Epileptic Encephalopathy, Lennox-Gastaut Type Seizures Adjuvants, Immunologic Central Nervous System Diseases Cutis Verticis Gyrata Brain Diseases |
Neuroprotective Agents Anti-Obesity Agents Signs and Symptoms Epilepsy Neurologic Manifestations Topiramate Anticonvulsants |
Epilepsies, Partial Physiological Effects of Drugs Seizures Nervous System Diseases Central Nervous System Diseases Brain Diseases Protective Agents Neuroprotective Agents Pharmacologic Actions |
Anti-Obesity Agents Signs and Symptoms Epilepsy Therapeutic Uses Neurologic Manifestations Topiramate Central Nervous System Agents Anticonvulsants |