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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.
ClinicalTrials.gov Identifier: NCT00181116
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 27, 2009
Sponsor:
Collaborator:
Information provided by:

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  (Clinical Trial)
Estimated 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
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Language improvement

Secondary Outcome Measures :
  1. Seizure control

Eligibility Criteria

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
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00181116


Locations
United States, Maryland
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
More Information

Publications:
ClinicalTrials.gov 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:
Epilepsy
Benign rolandic
Levetiracetam

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs