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Levetiracetam for Benign Rolandic Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181116
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 27, 2009
UCB Pharma
Information provided by:
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.

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
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 : March 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Primary Outcome Measures :
  1. Language improvement

Secondary Outcome Measures :
  1. Seizure control

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181116

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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
UCB Pharma
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Principal Investigator: Eric H Kossoff, MD Johns Hopkins University

Layout table for additonal information Identifier: NCT00181116     History of Changes
Other Study ID Numbers: 05-02-18-06
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009
Keywords provided by Johns Hopkins University:
Benign rolandic
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents