Clinical trial NCT00216567: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy, Rolandic
Keywords: Benign rolandic epilepsy
Topiramate
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 114
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, carbamazepine(target dose) 30mg/kg/day, B.I.D, oral, for 24 weeks.

Eligibility 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

Primary outcomes:
measure: Seizure-free rate at 24 weeks in comparison of topiramate to carbamazepine
Secondary outcomes:
measure: In comparison of topiramate to carbamazepine, Intellectual Functioning : KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for Children-Revised)
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: