New-Onset Epilepsy

Drug under Investigation:  Topiramate

Purpose of Study:  To evaluate the efficacy, tolerability and safety during the first month of treatment of monotherapy topiramate versus phenytoin sodium extended release (phenytoin) in subjects with seizures indicative of new onset epilepsy, and who require rapid initiation of oral AED therapy.

Inclusion Criteria:

• 12-65 years of age
• Must have had at least one but no more than 20 unprovoked partial or generalized tonic clonic seizures within the past 3 months.

Exclusion Criteria:

• Subjects who have taken AEDs in the 30 days prior to randomization.
• Subjects with seizures due to metabolic derangement, acute infectious etiology, drug intoxication, or alcohol withdrawal.
• Subjects with exclusively absence or myoclonic seizures.
• Subjects who have taken topiramate or phenytoin in the past six weeks.
• Female subjects who are pregnant.

If you qualify, all study related care is provided at no charge including:

• Study visits and study related procedures/tests
• Laboratory tests
• Study medication
• Financial compensation for time/travel expenses.

Inclusion/Exclusion Criteria Must Be Met