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

September 13, 2005
October 19, 2007
December 2002
 
Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine
Same as current
Complete list of historical versions of study NCT00216567 on ClinicalTrials.gov Archive Site
In comparison of topiramate to carbamazepine, Intellectual Functioning : KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for Children-Revised)
Same as current
 
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
A Randomized, Open Label, Comparative, Multi-Center Clinical Trial to Determine the Efficacy and Safety of Topiramate Comparing With Carbamazepine in Benign Rolandic Epilepsy.

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

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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Epilepsy, Rolandic
Drug: topamax
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
84
February 2006
 

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
Both
5 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00216567
 
CR005077
Janssen Korea, Ltd., Korea
 
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP