A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify patient characteristics (such as baseline seizure frequency) that may predict effective doses of topiramate using just that one drug (monotherapy) as initial therapy for epilepsy. Topiramate is an anti-epileptic drug that is approved for the treatment of epilepsy in adults and children 2 years of age and above.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Patients having new-onset epilepsy or epilepsy relapse characterized by partial-onset seizures or primary generalized tonic-clonic seizures

• having at least 1 seizure within the 3 months prior to entry

• who are previously untreated for epilepsy, previously treated for epilepsy, or if currently taking epilepsy medication, must have been taking it for less than 6 weeks

• weighing at least 25 kilograms (approximately 55 pounds)

• if female of childbearing potential, must be using an acceptable method of birth control

Exclusion Criteria:

• Patients who have previously taken topiramate for the treatment of epilepsy

• who are currently taking topiramate for any reason

• having active liver disease

• having a clinically significant medical condition or disease

• women who are pregnant or breastfeeding