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
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Condition or disease | Intervention/treatment | Phase |
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Epilepsy Complex Partial Seizures Epilepsy, Complex Partial Epilepsies, Partial | Drug: carisbamate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 991 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
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).
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Drug: 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).
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- 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 ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- In order to enter the open label extension, the patient must have completed either Study 333369EPY3001 or Study 333369EPY3002.
Exclusion Criteria:
- Generalized epilepsy
- Currently experiencing seizures that cannot be counted accurately
- Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
- Major psychiatric illness
- Recent drug or alcohol abuse
- Unable to swallow pills

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. |
Responsible Party: | SK Life Science |
ClinicalTrials.gov Identifier: | NCT00991757 History of Changes |
Other Study ID Numbers: |
333369EPY3004 |
First Posted: | October 8, 2009 Key Record Dates |
Last Update Posted: | June 18, 2013 |
Last Verified: | June 2013 |
Keywords provided by SK Life Science:
RWJ-333369 Anticonvulsants Antiepileptic drugs Epilepsy, Focal Seizure Disorder |
Additional relevant MeSH terms:
Epilepsy Seizures Epilepsies, Partial Epilepsy, Complex Partial Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |