Status:
COMPLETED
A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures
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 this study is to evaluate the efficacy and safety of topiramate as add-on therapy in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard...
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
- an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy
- during an 8-week baseline phase, patient must have at least 8 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 no seizure-free interval 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 :
May 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1992
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00236860
Start Date
May 1 1989
End Date
February 1 1992
Last Update
June 8 2011
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