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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00991757 |
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Date of registration:
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06/10/2009 |
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Primary sponsor: |
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Public title:
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An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures
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Scientific title:
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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 |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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991 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00991757 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- In order to enter the open label extension, the patient must have completed either
Study EPY3333698-EPY-3001 or Study 333369EPY-3002.
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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Complex Partial Seizures
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Epilepsies, Partial
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Epilepsy
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Epilepsy, Complex Partial
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Intervention(s)
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Drug: carisbamate
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Primary Outcome(s)
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Worsening of seizures, including rates of status epilepticus.
[Time Frame: Up to approximately 48 months]
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Secondary Outcome(s)
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Quality of Life in Epilepsy-31-Problems (QOLIE-31-P)
[Time Frame: month 6]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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