Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

This study has been completed.
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00216567
First received: September 13, 2005
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Epilepsy, Rolandic
Drug: topamax
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

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)

Enrollment: 114
Study Start Date: December 2002
Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216567

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00216567     History of Changes
Other Study ID Numbers: CR005077
Study First Received: September 13, 2005
Last Updated: January 31, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Benign rolandic epilepsy
Topiramate

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Carbamazepine
Topiramate
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 28, 2014