Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
NCT ID: NCT00215215
Last Updated: 2006-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
360 participants
INTERVENTIONAL
2005-02-28
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Vagus Nerve Stimulation Therapy
Eligibility Criteria
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Inclusion Criteria
* Patient has at least 4 complex partial seizures, but less than 25 seizures (any type), per month during the 3 months preceding randomization; for the 8 weeks preceding randomization, the seizure frequency should be confirmed from a patient diary.
* Patient has not had an adequate response to an adequate dosage of -- or was intolerant to -- a minimum of 2 different AEDs.
* Patient has (in the investigator's judgment) sufficient impairment from his/her epilepsy and/or epilepsy treatment that the potential benefits/risks of VNS therapy are warranted.
* Patient must currently be receiving at least one AED, but not more than three AEDs, in a stable dosage regimen for at least one month before randomization.
* Patient must be 12 years of age or older.
* Patient must be able to provide reliable seizure counts and to complete the evaluations specified in the study procedures flow chart.
* Patient must provide written informed consent, or legal guardian must give written permission and the minor provide written assent.
Exclusion Criteria
* Patient has had a bilateral or left cervical vagotomy.
* Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
* A VNS Therapy System implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient.
* Patient is expected to require full body magnetic resonance imaging during the clinical study.
* Patient has had a previous VNS Therapy System implant.
* Patient has a previous neuroimaging study that demonstrates mesial temporal sclerosis, cortical dysplasia, or a suspected brain tumor.
12 Years
ALL
No
Sponsors
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Cyberonics, Inc.
INDUSTRY
Principal Investigators
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Carol C Base, RN, MS
Role: STUDY_DIRECTOR
Cyberonics, Inc.
Locations
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Bronislav Shafran, M.D., P.C.
Phoenix, Arizona, United States
Xenoscience
Phoenix, Arizona, United States
Dedicated Clinical Research, Inc.
Sun City, Arizona, United States
USC Comprehensive Epilepsy Center
Los Angeles, California, United States
Certified Clinical Research
Roseville, California, United States
Pediatric Diagnostic Center
Ventura, California, United States
University of Florida, Department of Neurology
Gainesville, Florida, United States
Neurology Associates, P.A.
Maitland, Florida, United States
Child Neurology Center of Northwest Florida
Pensacola, Florida, United States
Pediatric Neurology of Idaho
Boise, Idaho, United States
Freeport Health Network, Department of Neurology
Freeport, Illinois, United States
Wayne State University School of Medicine, Department of Neurology
Detroit, Michigan, United States
Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center
New York, New York, United States
William Huffstutter, M.D.
Asheville, North Carolina, United States
Medford Neurological and Spine Clinic
Medford, Oregon, United States
Neurology and Sleep Medicine
Bethlehem, Pennsylvania, United States
Mid-South Physicians Group, P.L.L.C.
Germantown, Tennessee, United States
Hermann Hospital, UT Comprehensive Epilepsy Center
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Texas Association of Pediatric Neurology
San Antonio, Texas, United States
Pivotal Research Centers
Midvale, Utah, United States
Pharmaceutical Research Organization
South Ogden, Utah, United States
Regional Epilepsy Center Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Schachter SC. Vagus nerve stimulation therapy summary: five years after FDA approval. Neurology. 2002 Sep 24;59(6 Suppl 4):S15-20. doi: 10.1212/wnl.59.6_suppl_4.s15.
Renfroe JB, Wheless JW. Earlier use of adjunctive vagus nerve stimulation therapy for refractory epilepsy. Neurology. 2002 Sep 24;59(6 Suppl 4):S26-30. doi: 10.1212/wnl.59.6_suppl_4.s26.
Fisher RS, Handforth A. Reassessment: vagus nerve stimulation for epilepsy [RETIRED]: a report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 1999 Sep 11;53(4):666-9. doi: 10.1212/wnl.53.4.666. No abstract available.
Heck C, Helmers SL, DeGiorgio CM. Vagus nerve stimulation therapy, epilepsy, and device parameters: scientific basis and recommendations for use. Neurology. 2002 Sep 24;59(6 Suppl 4):S31-7. doi: 10.1212/wnl.59.6_suppl_4.s31.
Other Identifiers
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E-20
Identifier Type: -
Identifier Source: org_study_id