Back to resultsEffectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
Primary Purpose
Epilepsies, Partial
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vagus Nerve Stimulation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsies, Partial focused on measuring Vagus Nerve Stimulation Therapy, Epilepsies, Partial, Seizures, Antiepileptic Drugs, Refractory Partial Seizures
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Bronislav Shafran, M.D., P.C.
- Xenoscience
- Dedicated Clinical Research, Inc.
- USC Comprehensive Epilepsy Center
- Certified Clinical Research
- Pediatric Diagnostic Center
- University of Florida, Department of Neurology
- Neurology Associates, P.A.
- Child Neurology Center of Northwest Florida
- Pediatric Neurology of Idaho
- Freeport Health Network, Department of Neurology
- Wayne State University School of Medicine, Department of Neurology
- Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center
- William Huffstutter, M.D.
- Medford Neurological and Spine Clinic
- Neurology and Sleep Medicine
- Mid-South Physicians Group, P.L.L.C.
- Hermann Hospital, UT Comprehensive Epilepsy Center
- Texas Tech University Health Sciences Center
- Texas Association of Pediatric Neurology
- Pivotal Research Centers
- Pharmaceutical Research Organization
- Regional Epilepsy Center Saint Luke's Medical Center
Outcomes
Primary Outcome Measures
*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 Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00215215
Brief Title
Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Terminated
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cyberonics, Inc.
4. Oversight
5. Study Description
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.
Detailed Description
Published data suggest that patients who continue to experience seizures after trials of two or three AEDs are unlikely to become seizure-free with further attempts at pharmacotherapy. Such patients may experience poor quality of life and functional outcomes from continuing seizures and the adverse effects associated with further attempts at pharmacotherapy. VNS is a non-pharmacologic treatment for epilepsy with well-established effectiveness as an adjunctive treatment (to AEDs) for partial seizures refractory to AEDs, but there are no randomized clinical trials comparing the effectiveness of adjunctive VNS therapy with further pharmacotherapy alone in such patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
Vagus Nerve Stimulation Therapy, Epilepsies, Partial, Seizures, Antiepileptic Drugs, Refractory Partial Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation Therapy
Primary Outcome Measure Information:
Title
*Quality of Life in Epilepsy Questionnaire (QOLIE)
Title
at baseline, Week 26 and Week 52.
Title
*Patients will be asked to keep a daily record of their seizures in a seizure diary supplied by the investigational sites.
Secondary Outcome Measure Information:
Title
The QOLIE at baseline, Week 26 and Week 52.
Title
*Percentage Change in Seizure-Related Disability Assessment Scale (SERDAS)at baseline and Week 52 for each patient.
Title
*Percentage Change in Hospital Anxiety and Depression Scale (HAD)at baseline and Week 52 for each patient.
Title
*Over the course of the study, AED medications will be assessed.
Title
*Patient Satisfaction Survey will be performed at Week 52.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol C Base, RN, MS
Organizational Affiliation
Cyberonics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bronislav Shafran, M.D., P.C.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Dedicated Clinical Research, Inc.
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
USC Comprehensive Epilepsy Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Certified Clinical Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Pediatric Diagnostic Center
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
University of Florida, Department of Neurology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Neurology Associates, P.A.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Child Neurology Center of Northwest Florida
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Pediatric Neurology of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Freeport Health Network, Department of Neurology
City
Freeport
State/Province
Illinois
ZIP/Postal Code
61032
Country
United States
Facility Name
Wayne State University School of Medicine, Department of Neurology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
William Huffstutter, M.D.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Medford Neurological and Spine Clinic
City
Medford
State/Province
Oregon
ZIP/Postal Code
997504
Country
United States
Facility Name
Neurology and Sleep Medicine
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Mid-South Physicians Group, P.L.L.C.
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Hermann Hospital, UT Comprehensive Epilepsy Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Texas Association of Pediatric Neurology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Pivotal Research Centers
City
Midvale
State/Province
Utah
ZIP/Postal Code
84047
Country
United States
Facility Name
Pharmaceutical Research Organization
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Regional Epilepsy Center Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12270963
Citation
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.
Results Reference
background
PubMed Identifier
12270965
Citation
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.
Results Reference
background
PubMed Identifier
10489023
Citation
Fisher RS, Handforth A. Reassessment: vagus nerve stimulation for epilepsy: 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.
Results Reference
background
PubMed Identifier
12270966
Citation
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.
Results Reference
background
Learn more about this trial
Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
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