Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Carbamazepine; Topiramate

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