Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

• ClinicalTrials.gov Identifier: NCT00216567
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: February 1, 2011
• Sponsor: Janssen Korea, Ltd., Korea
• Information provided by: Janssen Korea, Ltd., Korea

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy, Rolandic	Drug: topamax	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: December 2002
• Actual Study Completion Date: February 2006

Arms and Interventions

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)

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

• Study Director: Janssen Korea, Ltd. Clinical Trial; Janssen Korea, Ltd.

More Information

• ClinicalTrials.gov Identifier: NCT00216567
• Other Study ID Numbers: CR005077
• First Posted: September 22, 2005
• Last Update Posted: February 1, 2011
• Last Verified: January 2011

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; Epileptic Syndromes; Topiramate; Anticonvulsants; Hypoglycemic Agents; Physiological Effects of Drugs