Levetiracetam for Benign Rolandic Epilepsy

Epilepsy Clinical Trial

Official title:

Efficacy of Levetiracetam for Language Dysfunction Associated With Benign Epilepsy With Centrotemporal Spikes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181116
• Other study ID #: 05-02-18-06
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2005
• Last updated: March 26, 2009
• Start date: March 2005
• Est. completion date: September 2006

Study information

• Verified date: March 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	UCB Pharma

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bello-Espinosa LE, Roberts SL. Levetiracetam for benign epilepsy of childhood with centrotemporal spikes-three cases. Seizure. 2003 Apr;12(3):157-9. — View Citation

Kossoff EH, Boatman D, Freeman JM. Landau-Kleffner syndrome responsive to levetiracetam. Epilepsy Behav. 2003 Oct;4(5):571-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Language improvement
Secondary	Seizure control