Status:
COMPLETED
A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief 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 requ...
Detailed Description
In this study, patients who have recently been diagnosed with epilepsy and who require rapid initiation of treatment will be randomized to receive either phenytoin or topiramate. Patients have an equa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT00210782
Start Date
June 1 2004
End Date
August 1 2007
Last Update
June 10 2011
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