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History of Changes for Study: NCT00216567
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
Latest version (submitted January 31, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 13, 2005 None (earliest Version on record)
2 December 2, 2005 Study Status, Arms and Interventions and Study Identification
3 December 13, 2005 Eligibility, Study Status and Study Identification
4 October 19, 2007 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Oversight and Study Identification
5 April 23, 2010 Study Status and Study Identification
6 January 20, 2011 Study Status, Study Design and Contacts/Locations
7 January 31, 2011 Eligibility, Study Description and Study Status
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Study NCT00216567
Submitted Date:  September 13, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR005077
Brief Title: Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2005
Overall Status: Active, not recruiting
Study Start: December 2002
Primary Completion:
Study Completion:
First Submitted: September 13, 2005
First Submitted that
Met QC Criteria:
September 13, 2005
First Posted: September 22, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 13, 2005
Last Update Posted: September 22, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Korea, Ltd., Korea
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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) 4mg/kg/day, B.I.D, oral, for 24 weeks, cabamazepine(target dose) 30mg/kg/day, B.I.D, oral, for 24 weeks.

Open or close this module Conditions
Conditions: Epilepsy, Rolandic
Keywords: Benign rolandic epilepsy
Topiramate
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 84
Open or close this module Arms and Interventions
Intervention Details:
Drug: Topamax
Open or close this module Outcome Measures
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)
Open or close this module Eligibility
Minimum Age: 5 Years
Maximum Age: 15 Years
Sex: All
Gender Based:
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

Open or close this module Contacts/Locations
Study Officials: Janssen Korea, Ltd., Korea Clinical Trial
Study Director
Janssen Korea, Ltd., Korea
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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