Status:
COMPLETED
A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
Lead Sponsor:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Conditions:
Seizures
Epilepsy
Eligibility:
All Genders
2+ years
Brief Summary
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.
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 expan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00297349
Start Date
November 1 2003
End Date
June 1 2005
Last Update
April 27 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.