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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
Information provided by:
Janssen Korea, Ltd., Korea

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 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
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

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

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

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

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

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

ClinicalTrials.gov Identifier: NCT00216567     History of Changes
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

Additional relevant MeSH terms:
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action