Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

Sponsor

Janssen Korea, Ltd., Korea (Industry)

Overall Status

Completed

CT.gov ID

NCT00216567

Collaborator

(none)

114

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy, Rolandic	Drug: topamax	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2002

Actual Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00216567

Other Study ID Numbers:

CR005077

First Posted:

Sep 22, 2005

Last Update Posted:

Feb 1, 2011

Last Verified:

Jan 1, 2011

Keywords provided by , ,

Benign rolandic epilepsy

Topiramate

Additional relevant MeSH terms:

Epilepsy

Epilepsy, Rolandic

Topiramate

Study Results

No Results Posted as of Feb 1, 2011