Status:
COMPLETED
A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.
Detailed Description
Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). This is a randomized, double-blind, parallel-group study to ev...
Eligibility Criteria
Inclusion
- Body weight of at least 30 kilograms
- New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry
- No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks
- Females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry
Exclusion
- Patients who do not have epilepsy
- Have progressive or degenerative disorders (for example, certain hereditary conditions)
- Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases)
- Have mental retardation or other condition that could make interpretation of the study results difficult
- alcohol or drug abuse within the previous year
Key Trial Info
Start Date :
September 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2000
Estimated Enrollment :
865 Patients enrolled
Trial Details
Trial ID
NCT00236717
Start Date
September 1 1997
End Date
November 1 2000
Last Update
June 8 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.