Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy (NCT00216567) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
114 participantsStarted 2002-12
Plain-language summary
The purpose of this study is to determine the efficacy and safety of Topiramate in comparison to Carbamazepine in Benign rolandic epilepsy.
Who can participate
Age range5 Years – 15 Years
SexALL
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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
What they're measuring
1
Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine