Levetiracetam for Benign Rolandic Epilepsy

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181116
First received: September 10, 2005
Last updated: March 26, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181116

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
UCB, Inc.
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
Study First Received: September 10, 2005
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014