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 patients with difficult to control partial onset seizures who are taking one or two standard antiepi...
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 anti-epileptic 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
- Females who are capable of having children
- patients with treatable causes of seizures (for example, infections)
- patients with a progressive disorder of the nervous system
- patients with history of status epilepticus (repeated or prolonged seizures) while on antiepileptic therapy
- history of serious disease of the heart, liver, kidneys, gastrointestinal, metabolic, or endocrine system
- history of alcohol or drug abuse within one year prior to study initiation.
Key Trial Info
Start Date :
July 1 1988
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1990
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00236691
Start Date
July 1 1988
End Date
December 1 1990
Last Update
June 8 2011
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