Back to resultsLevetiracetam for Benign Rolandic Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Benign rolandic, Levetiracetam
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital
Outcomes
Primary Outcome Measures
Language improvement
Secondary Outcome Measures
Seizure control
Full Information
NCT ID
NCT00181116
First Posted
September 10, 2005
Last Updated
March 26, 2009
Sponsor
Johns Hopkins University
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00181116
Brief Title
Levetiracetam for Benign Rolandic Epilepsy
Official Title
Efficacy of Levetiracetam for Language Dysfunction Associated With Benign Epilepsy With Centrotemporal Spikes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
UCB Pharma
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Benign rolandic, Levetiracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Primary Outcome Measure Information:
Title
Language improvement
Secondary Outcome Measure Information:
Title
Seizure control
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric H Kossoff, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12651081
Citation
Bello-Espinosa LE, Roberts SL. Levetiracetam for benign epilepsy of childhood with centrotemporal spikes-three cases. Seizure. 2003 Apr;12(3):157-9. doi: 10.1016/s1059-1311(03)00004-9.
Results Reference
background
PubMed Identifier
14527502
Citation
Kossoff EH, Boatman D, Freeman JM. Landau-Kleffner syndrome responsive to levetiracetam. Epilepsy Behav. 2003 Oct;4(5):571-5. doi: 10.1016/s1525-5050(03)00171-9.
Results Reference
background
Learn more about this trial
Levetiracetam for Benign Rolandic Epilepsy
We'll reach out to this number within 24 hrs