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Terminated Phase 4 Interventional

Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures

ClinicalTrials.gov ID: NCT00215215

Public ClinicalTrials.gov record NCT00215215. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 9:25 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00215215
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Cyberonics, Inc.
Industry
Enrollment
360 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2005 (Type not available)
Primary completion
Not listed
Completion
Nov 2007 (Type not available)
Last update posted
Feb 22, 2006

2005 – 2007

United States locations

U.S. sites
23
U.S. states
14
U.S. cities
22
Facility City State ZIP Site status
Bronislav Shafran, M.D., P.C. Phoenix Arizona 85003 —
Xenoscience Phoenix Arizona 85013 —
Dedicated Clinical Research, Inc. Sun City Arizona 85351 —
USC Comprehensive Epilepsy Center Los Angeles California 90033 —
Certified Clinical Research Roseville California 95661 —
Pediatric Diagnostic Center Ventura California 93003 —
University of Florida, Department of Neurology Gainesville Florida 32610 —
Neurology Associates, P.A. Maitland Florida 32751 —
Child Neurology Center of Northwest Florida Pensacola Florida 32504 —
Pediatric Neurology of Idaho Boise Idaho 83712 —
Freeport Health Network, Department of Neurology Freeport Illinois 61032 —
Wayne State University School of Medicine, Department of Neurology Detroit Michigan 48201 —
Weill-Cornell Medical College, N.Y. Presbyterian Hospital, Comprehensive Epilepsy Center New York New York 10021 —
William Huffstutter, M.D. Asheville North Carolina 28801 —
Medford Neurological and Spine Clinic Medford Oregon 997504 —
Neurology and Sleep Medicine Bethlehem Pennsylvania 18015 —
Mid-South Physicians Group, P.L.L.C. Germantown Tennessee 38138 —
Hermann Hospital, UT Comprehensive Epilepsy Center Houston Texas 77030 —
Texas Tech University Health Sciences Center Lubbock Texas 79430 —
Texas Association of Pediatric Neurology San Antonio Texas 78258 —
Pivotal Research Centers Midvale Utah 84047 —
Pharmaceutical Research Organization South Ogden Utah 84403 —
Regional Epilepsy Center Saint Luke's Medical Center Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00215215, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 22, 2006 · Synced Nov 3, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00215215 live on ClinicalTrials.gov.

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