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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00228969 |
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Date of registration:
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30/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
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Scientific title:
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Date of first enrolment:
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February 2005 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00228969 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Hungary
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Netherlands
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Poland
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Russian Federation
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Spain
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18-70 years old,
2. Diagnosis of epilepsy for at least 1 year,
3. Presenting, on average, at least 3 partial onset seizures per month,
4. Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3
anti-epileptic drugs (AEDs),
Exclusion Criteria:
1. Have experienced status epilepticus in the past 3 months,
2. Have any serious diseases,
3. History of major psychiatric disorders within the past 2 years.
4. Have received an experimental drug/device within the past 30 days
5. Are pregnant or breastfeeding.
Age minimum:
18 Years
Age maximum:
79 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Refractory Epilepsy
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Intervention(s)
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Drug: RWJ-333369
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Secondary ID(s)
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333369-EPY-2003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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