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

February 20, 2006 updated by: Cyberonics, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
*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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyberonics, Inc.

Investigators

  • Study Director: Carol C Base, RN, MS, Cyberonics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion

November 1, 2007

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 22, 2006

Last Update Submitted That Met QC Criteria

February 20, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsies, Partial

Clinical Trials on Vagus Nerve Stimulation Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe