A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
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|ClinicalTrials.gov Identifier: NCT00433667|
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : June 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Epilepsy, Focal Seizure Disorder Complex Partial Seizures Epilepsy, Complex Partial||Drug: RWJ-333369||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||563 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Epilepsy Phase III Trial|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
- The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
- The key secondary outcome is the change in the Seizure Severity Questionnaire score.
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): NCT00433667
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|