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Levetiracetam for Benign Rolandic Epilepsy

This study has been completed.
UCB Pharma
Information provided by:
Johns Hopkins University Identifier:
First received: September 10, 2005
Last updated: March 26, 2009
Last verified: March 2009
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 Intervention Phase
Epilepsy Drug: Levetiracetam Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Language improvement

Secondary Outcome Measures:
  • Seizure control

Estimated Enrollment: 6
Study Start Date: March 2005
Study Completion Date: September 2006
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.

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
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Please refer to this study by its identifier: NCT00181116

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

Publications: Identifier: NCT00181116     History of Changes
Other Study ID Numbers: 05-02-18-06
Study First Received: September 10, 2005
Last Updated: March 26, 2009

Keywords provided by Johns Hopkins University:
Benign rolandic

Additional relevant MeSH terms:
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on September 19, 2017