Status:
COMPLETED
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Epilepsies, Partial
Eligibility:
All Genders
1-16 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of oral topiramate as add-on therapy in children with uncontrolled partial onset seizures who are taking one or two standard anti-...
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
- Patients must weigh at least 36 pounds (16 kilograms)
- patients must have partial onset seizures (with or without secondarily generalized seizures) being treated with at least one, but no more than two antiepileptic drugs (AEDs)
- patients must have at least 6 partial onset seizures during the 8-week baseline phase, with at least one seizure during each 4-week period
- an electroencephalogram (EEG) with features consistent with partial epilepsy performed prior to study initiation or during the baseline phase
Exclusion
- Females who are pregnant, nursing, or those not using adequate birth control if capable of having children
- patients with a treatable cause of seizures (for example, infections)
- patients with a progressive disorder of the nervous system
- patients with a clinical diagnosis of Lennox-Gastaut syndrome
- patients with a history of generalized status epilepticus (repeated or prolonged seizures) while on appropriate anti-epileptic therapy
Key Trial Info
Start Date :
June 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2000
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00236743
Start Date
June 1 1994
End Date
October 1 2000
Last Update
June 8 2011
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