A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
|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|
|Primary Completion Date :||October 2007|
|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.
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.|