Status:
COMPLETED
A Study of the Efficacy and Safety of Topiramate Treatment in Patients With Epilepsy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Seizures
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of topiramate (an antiepileptic medication) in patients with epilepsy.
Detailed Description
Epilepsy is a disease characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," origina...
Eligibility Criteria
Inclusion
- Body weight \>90 pounds
- documented history of frequent partial onset seizures
- at least four partial onset seizures per month while taking a constant antiepileptic drug dosage during the screening period
- a recent history of maintenance on 1 or 2 standard antiepileptic drugs
- females must be postmenopausal for at least 1 year, or if of childbearing age, 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, such as patients with treatable causes of seizure (for example, cancer or active infection)
- have a documented history (previous 3 months) of generalized status epilepticus while receiving anticonvulsant medication (status epilepticus is a prolonged seizure or seizures repeated frequently over 20 to 30 minutes so that recovery between episodes does not occur)
- have seizures occurring in only clustered patterns (numerous seizures over a short period of time)
- a significant history (within 2 years) of medical disease (heart, kidney, hormone, gynecologic, muscle, bone, gastrointestinal, metabolic, liver diseases or cancer with a metastatic potential)
- history of alcohol or drug abuse history within the past 1 year.
Key Trial Info
Start Date :
October 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1997
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00266591
Start Date
October 1 1992
End Date
April 1 1997
Last Update
June 8 2011
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