Status:
COMPLETED
An Observational Study of the Safety of Topiramate in Adults and Children With Epilepsy
Lead Sponsor:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Conditions:
Seizures, Epileptic
Eligibility:
All Genders
2+ years
Brief Summary
The purpose of this observational study is to evaluate the safety of topiramate in adults and children with epilepsy (or seizures) who have not received or have not responded to treatment with previou...
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
- Patients who have not received previous treatment with antiepileptic medications or patients who did not respond to previous treatment with antiepileptic medications, defined as a lack of effectiveness of the medication(s), or the inability to take the medication(s) due to adverse effects
Exclusion
- Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor and are manageable
- Patients with a hypersensitivity to topiramate or to some of its components
- Patients who should not take Topiramate for reasons listed in its approved Summary of Product Characteristics (printed information about a medication that describes its actions, side effects and intended patients)
- Patients who are uncooperative or for whom obtaining compliance with study visit schedules and procedures and information required by the study would be difficult
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00297323
Start Date
June 1 2005
End Date
February 1 2007
Last Update
April 27 2010
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