Levetiracetam for Benign Rolandic Epilepsy

Phase 4

Completed

• Conditions: Epilepsy

• Registration Number: NCT00181116
• Lead Sponsor: Johns Hopkins University

Brief Summary

This study is designed to test if the language problems commonly seen in children with benign rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.

Detailed Description

This is a 6 month study in which children on another anticonvulsant would have EEG, language testing, and a clinic visit at baseline. They would then be rapidly transitioned off of their current anticonvulsant and onto levetiracetam (Keppra). Repeat EEG and language testing would be done after 6 months to evaluate for improvement.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Study Completion: 2006-09
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-26
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Ages 6-12
• Benign rolandic epilepsy
• Language difficulties as reported by parents or teachers
• On another anticonvulsant other than levetiracetam

Exclusion Criteria

• Prior use of levetiracetam
• On 2 or more anticonvulsants
• Language problems prior to epilepsy
• Another seizure disorder
• Status epilepticus within the past 6 months
• Significant psychiatric disease
• Progressive neurologic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Language improvement

Secondary Outcome Measures

Name	Time	Method
Seizure control

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States