Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
Post Marketing Study; Randomized, Parallel-Group Comparison of Treatment With Pharmacotherapy or Adjunctive Vagus Nerve Stimulation Therapy for Pharmacoresistant Partial Seizures: A Large Simple Effectiveness Trial
1 other identifier
interventional
360
1 country
23
Brief Summary
To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures refractory to at least two, but not more than five, AEDs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2005
Typical duration for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFebruary 22, 2006
February 1, 2006
September 16, 2005
February 20, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
*Quality of Life in Epilepsy Questionnaire (QOLIE)
at baseline, Week 26 and Week 52.
*Patients will be asked to keep a daily record of their seizures in a seizure diary supplied by the investigational sites.
Secondary Outcomes (5)
The QOLIE at baseline, Week 26 and Week 52.
*Percentage Change in Seizure-Related Disability Assessment Scale (SERDAS)at baseline and Week 52 for each patient.
*Percentage Change in Hospital Anxiety and Depression Scale (HAD)at baseline and Week 52 for each patient.
*Over the course of the study, AED medications will be assessed.
*Patient Satisfaction Survey will be performed at Week 52.
Interventions
Eligibility Criteria
You may qualify if:
- Patient has a diagnosis of partial seizures with onset before age 50, and the patient's prior electroencephalography and magnetic resonance imaging studies are consistent with the diagnosis of partial seizures.
- 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.
You may not qualify if:
- Patient has a history (lifetime) of having received more than 5 different AEDs.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cyberonics, Inc.lead
Study Sites (23)
Bronislav Shafran, M.D., P.C.
Phoenix, Arizona, 85003, United States
Xenoscience
Phoenix, Arizona, 85013, United States
Dedicated Clinical Research, Inc.
Sun City, Arizona, 85351, United States
USC Comprehensive Epilepsy Center
Los Angeles, California, 90033, United States
Certified Clinical Research
Roseville, California, 95661, United States
Pediatric Diagnostic Center
Ventura, California, 93003, United States
University of Florida, Department of Neurology
Gainesville, Florida, 32610, United States
Neurology Associates, P.A.
Maitland, Florida, 32751, United States
Child Neurology Center of Northwest Florida
Pensacola, Florida, 32504, United States
Pediatric Neurology of Idaho
Boise, Idaho, 83712, United States
Freeport Health Network, Department of Neurology
Freeport, Illinois, 61032, United States
Wayne State University School of Medicine, Department of Neurology
Detroit, Michigan, 48201, United States
Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center
New York, New York, 10021, United States
William Huffstutter, M.D.
Asheville, North Carolina, 28801, United States
Medford Neurological and Spine Clinic
Medford, Oregon, 997504, United States
Neurology and Sleep Medicine
Bethlehem, Pennsylvania, 18015, United States
Mid-South Physicians Group, P.L.L.C.
Germantown, Tennessee, 38138, United States
Hermann Hospital, UT Comprehensive Epilepsy Center
Houston, Texas, 77030, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Texas Association of Pediatric Neurology
San Antonio, Texas, 78258, United States
Pivotal Research Centers
Midvale, Utah, 84047, United States
Pharmaceutical Research Organization
South Ogden, Utah, 84403, United States
Regional Epilepsy Center Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (4)
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.
PMID: 12270963BACKGROUNDRenfroe 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.
PMID: 12270965BACKGROUNDFisher 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.
PMID: 10489023BACKGROUNDHeck 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.
PMID: 12270966BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carol C Base, RN, MS
Cyberonics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
February 1, 2005
Study Completion
November 1, 2007
Last Updated
February 22, 2006
Record last verified: 2006-02