A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
|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|
|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.
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.|