Status:
COMPLETED
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Epilepsy, Rolandic
Eligibility:
All Genders
5-15 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the efficacy and safety of Topiramate in comparison to Carbamazepine in Benign rolandic epilepsy.
Detailed Description
Benign rolandic epilepsy (BRE) is a common seizure disorder confined solely to children. The disorder is marked clinically by nocturnal generalized tonic-clonic seizures and diurnal seizures consistin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00216567
Start Date
December 1 2002
End Date
February 1 2006
Last Update
February 1 2011
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