Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216567
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2005-09-13
Brief Title:
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
Sponsor:
Janssen Korea Ltd Korea
Organization:
Janssen Korea Ltd Korea
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the efficacy and safety of Topiramate in comparison to Carbamazepine in Benign rolandic epilepsy
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 4mgkgday BID oral for 24 weeks carbamazepinetarget dose 30mgkgday BID oral for 24 weeks
Topiramate target dose 4mgkgday BID oral for 24 weeks carbamazepinetarget dose 30mgkgday BID oral for 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None