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: NCT00425282|
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : June 20, 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 :||566 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures Followed by an Open-Label Extension Study.|
|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.
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): NCT00425282
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|