An Observational Study of the Safety of Topiramate in Adults and Children With Epilepsy

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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 previous antiepileptic medication.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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