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.
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|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 ]
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): NCT00991757
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|