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.”

The purpose of this study is to determine the efficacy and safety of Topiramate in comparison to Carbamazepine in Benign rolandic epilepsy.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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, cabamazepine(target dose) 30mg/kg/day, B.I.D, oral, for 24 weeks.

Intervention(s) in this Clinical Trial

• Drug: topamax

Primary Measures

• Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine

Secondary Measures

• In comparison of topiramate to carbamazepine, Intellectual Functioning : KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for Children-Revised)

Inclusion Criteria:

• Subjects whose guardians submitted written consent
• Subjects with more than 2 seizures in last 1 year
• Subjects showing oneof the following additional criteria
• Psychological burden due to seizure
• Seizure in daytime
• More than 3 seizures in last 6 month
• Convulsive seizure

Exclusion Criteria:

• Abnormalties 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 15 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen Korea, Ltd., Korea

Overall Clinical Trial Officials and Contacts

Janssen Korea, Ltd. Clinical Trial Study Director Janssen Korea, Ltd., Korea  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00216567

Study ID Number: CR005077

ClinicalTrials.gov Identifier: NCT00216567

Health Authority: Korea: Food and Drug Administration