Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

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ClinicalTrials.gov Identifier: NCT00216567

Recruitment Status : Completed

First Posted : September 22, 2005

Last Update Posted : February 1, 2011

Sponsor:

Information provided by:

Janssen Korea, Ltd., Korea

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

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Study Type :	Interventional (Clinical Trial)
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 :	December 2002
Actual Study Completion Date :	February 2006

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Epilepsy-aphasia spectrum Pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Carbamazepine Topiramate

U.S. FDA Resources

Arms and Interventions

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

Information from the National Library of Medicine

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Ages Eligible for Study:	5 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216567

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

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

More Information

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ClinicalTrials.gov Identifier:	NCT00216567
Other Study ID Numbers:	CR005077
First Posted:	September 22, 2005 Key Record Dates
Last Update Posted:	February 1, 2011
Last Verified:	January 2011

Keywords provided by Janssen Korea, Ltd., Korea:


Benign rolandic epilepsy Topiramate

Additional relevant MeSH terms:

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Epilepsy Epilepsy, Rolandic Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial Epileptic Syndromes Topiramate Carbamazepine Anticonvulsants Hypoglycemic Agents Physiological Effects of Drugs Antimanic Agents	Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers

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