Status:
COMPLETED
A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
10+ years
Phase:
PHASE4
Brief 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 t...
Detailed Description
Any number of factors could affect the dosage needs for an anti-epileptic medication, however, various lines of evidence suggest that characteristics of the patient's epilepsy itself could be importan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT00266604
Start Date
December 1 2005
End Date
June 1 2007
Last Update
June 10 2011
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