Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy, Rolandic
Intervention: topamax (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s):
Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd.
Summary
The purpose of this study is to determine the efficacy and safety of Topiramate in
comparison to Carbamazepine in Benign rolandic epilepsy.
Clinical Details
Official title: A Randomized, Open Label, Comparative, Multi-center Clinical Trial to Determine the Efficacy and Safety of Topiramate Comparing With Carbamazepine in Benign Rolandic Epilepsy.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine
Secondary outcome: In comparison of topiramate to carbamazepine, Intellectual Functioning : KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for Children-Revised)
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 consisting of simple partial seizures consisting of brief unilateral facial clonic
activity, dysphasia, and drooling. The EEG abnormalities are unique, consisting of generally
high amplitude, centrotemporal spikes that are activated by sleep. The seizures typically
begin in the first decade and almost always stop by age 16 years. The seizures are usually
infrequent although clusters of seizures do occur. When the physician elects to treat, the
seizures are usually easily controlled. This is a randomized, open label, active controlled,
multi-center based clinical trial to determine the efficacy and safety of Topiramate
comparing with Carbamazepine in Benign rolandic epilepsy. The study hypothesis is that
topiramate will be more effective in treatment of Benign rolandic epilepsy than
Carbamazepine, as evaluated by seizure-free rate at 24 weeks and Intellectual Functioning :
KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for
Children-Revised) and is generally well-tolerated.
Topiramate (target dose) 4mg/kg/day, B. I.D, oral, for 24 weeks, carbamazepine(target dose)
30mg/kg/day, B. I.D, oral, for 24 weeks.
Eligibility
Minimum age: 5 Years.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: December 2002
Last updated: January 31, 2011
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