Epilepsy Clinical Trial
Official title:
Double-Blind Parallel Comparison of Topiramate 200 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard antiepileptic drugs.
Status | Completed |
Enrollment | 47 |
Est. completion date | May 1993 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 - female patients who are pregnant or nursing, or those not using adequate birth control if capable of having children |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Sharief M, Viteri C, Ben-Menachem E, Weber M, Reife R, Pledger G, Karim R. Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Epilepsy Res. 1996 Nov;25(3):217-24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent reduction in the average monthly seizure rate from baseline to end of treatment | |||
Secondary | Percent of patients responding to treatment. Percent reduction in generalized seizures. Patient's and investigator's global assessments at end of study and incidence of adverse events throughout study. |
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