Clinical Trial: Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Janssen Korea, Ltd., Korea

Current Primary Outcome: Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Janssen Korea, Ltd., Korea

Dates:
Date Received: September 13, 2005
Date Started: December 2002
Date Completion:
Last Updated: January 31, 2011
Last Verified: January 2011