Levetiracetam for Benign Rolandic Epilepsy

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00181116
• Collaborator: UCB Pharma (Industry)
• Enrollment: 6
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Levetiracetam	Phase 4

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Levetiracetam for Language Dysfunction Associated With Benign Epilepsy With Centrotemporal Spikes
• Study Start Date: Mar 1, 2005
• Actual Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. Language improvement []

Secondary Outcome Measures

1. Seizure control []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• UCB Pharma

Investigators

• Principal Investigator: Eric H Kossoff, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bello-Espinosa LE, Roberts SL. Levetiracetam for benign epilepsy of childhood with centrotemporal spikes-three cases. Seizure. 2003 Apr;12(3):157-9.
• Kossoff EH, Boatman D, Freeman JM. Landau-Kleffner syndrome responsive to levetiracetam. Epilepsy Behav. 2003 Oct;4(5):571-5.

• ClinicalTrials.gov Identifier: NCT00181116
• Other Study ID Numbers: 05-02-18-06
• First Posted: Sep 16, 2005
• Last Update Posted: Mar 27, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Epilepsy; Benign rolandic; Levetiracetam
• Additional relevant MeSH terms: Epilepsy; Levetiracetam

Study Results

No Results Posted as of Mar 27, 2009