A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Seizures indicative of new-onset epilepsy (or epilepsy relapse) of untreated epilepsy

• at least one but not more than 20 unprovoked seizures within past 3 months

• weighing more than 110 pounds

• considered to be a good candidate for rapid initiation of anti-seizure medication

• able to swallow a tablet whole (without crushing it).

Exclusion Criteria:

• Not having taken anti-seizure medications within the past 30 days

• no provoking factors for seizures (presence of alcohol withdrawal, drug intoxication, acute meningitis or encephalitis, acute head injury or stroke, acute hypoxic/ischemic encephalopathy, or brain tumor)

• no presence of active liver disease or serious kidney disease

• not pregnant or breast-feeding

• not using birth control.