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A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures.
This study has been completed.
Sponsored by: Janssen Cilag Pharmaceutica S.A.C.I., Greece
Information provided by: Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier: NCT00297349
  Purpose

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
Epilepsy
Seizures
Drug: topiramate
Phase IV

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Topiramate
U.S. FDA Resources
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.

Further study details as provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:

Estimated Enrollment: 165
Study Start Date: November 2003
Estimated Study Completion Date: June 2005
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297349

Sponsors and Collaborators
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Investigators
Study Director: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Janssen Cilag Pharmaceutica S.A.C.I., Greece
  More Information

Study ID Numbers: CR003472
Study First Received: February 24, 2006
Last Updated: October 19, 2007
ClinicalTrials.gov Identifier: NCT00297349  
Health Authority: Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines

Keywords provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:
Lennox-Gastaut Syndrome
Seizures
Focal Epilepsy
Epilepsy in Children
Topiramate
Epilepsy
Tonic-clonic

Study placed in the following topic categories:
Epilepsies, Partial
Signs and Symptoms
Epilepsy
Epileptic encephalopathy, Lennox-Gastaut type
Seizures
Topiramate
Cutis verticis gyrata
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:
Anti-Obesity Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009