Status:
COMPLETED
A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Epilepsies, Partial
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard ant...
Detailed Description
Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in bo...
Eligibility Criteria
Inclusion
- History of simple or complex partial epilepsy that has been documented or witnessed
- during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs)
- and have no more than one seizure-free interval of up to 3 weeks and none longer than 3 weeks
- good physical health.
Exclusion
- Patients having solely generalized seizures or lacking documentation of partial epilepsy
- patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy
- generalized seizures, which are defined by the EEG wave pattern
- seizures that lack an abnormal pulsation pattern on EEG
- females who are capable of having children
Key Trial Info
Start Date :
June 1 1988
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1990
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00236730
Start Date
June 1 1988
End Date
December 1 1990
Last Update
June 8 2011
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