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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: |
NCT00216567 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
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Scientific title:
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A Randomized, Open Label, Comparative, Multi-center Clinical Trial to Determine the Efficacy and Safety of Topiramate Comparing With Carbamazepine in Benign Rolandic Epilepsy. |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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114 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00216567 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Janssen Korea, Ltd. 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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Janssen Korea, Ltd. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects whose guardians submitted written consent
- Subjects with more than 2 seizures in last 1 year
- Subjects showing one of the following additional criteria
- Psychological burden due to seizure
- Seizure in daytime
- More than 3 seizures in last 6 month
- Convulsive seizure
Exclusion Criteria:
- Abnormalities on MRI, EEG
- Mental retardation
- History of seizure relapse
- Seizures due to organic causes
- Medically serious acute or chronic disease or progressive and degenerative disorders
- Patients who have received an investigational medication
Age minimum:
5 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy, Rolandic
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Intervention(s)
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Drug: topamax
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Primary Outcome(s)
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Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine
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Secondary Outcome(s)
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In comparison of topiramate to carbamazepine, Intellectual Functioning : KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for Children-Revised)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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