An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.
|ClinicalTrials.gov Identifier: NCT00991757|
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : June 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Complex Partial Seizures Epilepsy, Complex Partial Epilepsies, Partial||Drug: carisbamate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||991 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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: Open-Label Extension Period|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
carisbamate Open-Label Extension: 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses for up to 1 year (or until carisbamate is available by prescription or the sponsor terminates the study).
Open-Label Extension: 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses for up to 1 year (or until carisbamate is available by prescription or the sponsor terminates the study).
- Worsening of seizures, including rates of status epilepticus. [ Time Frame: Up to approximately 48 months ]
- Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) [ Time Frame: month 6 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991757
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|