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Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
This study has been completed.
First Received: September 13, 2005   Last Updated: October 19, 2007   History of Changes
Sponsor: Janssen Korea, Ltd., Korea
Information provided by: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00216567
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Estimated Enrollment: 84
Study Start Date: December 2002
Estimated 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, cabamazepine(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 oneof the following additional criteria
  • Psychological burden due to seizure
  • Seizure in daytime
  • More than 3 seizures in last 6 month
  • Convulsive seizure

Exclusion Criteria:

  • Abnormalties 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
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., Korea
  More Information

No publications provided

Study ID Numbers: CR005077
Study First Received: September 13, 2005
Last Updated: October 19, 2007
ClinicalTrials.gov Identifier: NCT00216567     History of Changes
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 09, 2009