A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures
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|ClinicalTrials.gov Identifier: NCT00236418|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Seizures||Drug: topiramate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Topiramate Clinical Trial in Primary Generalized Tonic-Clonic Seizures|
|Study Start Date :||December 1994|
|Actual Study Completion Date :||December 1996|
- Percent reduction from baseline in primary generalized tonic-clonic seizure rates and percent responders (>=50% reduction in PGTC seizure rate from baseline), during the double-blind phase. Subjects' global evaluation of improvement in seizure severity.
- Percent reduction from baseline of all seizure types and percent of treatment responders in all seizure types, during the double-blind phase. Safety evaluations conducted throughout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236418
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|