Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated (V-COMPAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Cyberonics, Inc.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01281293
First received: January 5, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

Vagal Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy since 1994. This post-market study is designed to follow the clinical course and outcomes for patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency, seizure severity, side effects burden, depressive symptoms, global impressions, and health care utilization will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of VNS Therapy for patients with refractory seizures who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected is not for the purposes of confirmatory assessment.


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Market, Long Term, Prospective, Observational, Multi-site Outcome Study to Follow the Clinical Course and Seizure Reduction of Patients With Refractory Seizures Who Are Being Treated With Adjunctive VNS Therapy.

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Two-Year Clinical Follow-up [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    To follow the clinical course of patients with refractory seizures treated with adjunctive VNS Therapy over a two-year follow-up period.


Secondary Outcome Measures:
  • Efficacy and Safety [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    1. To evaluate over time the efficacy of best medical practice with adjunctive VNS Therapy in patients with refractory seizures.
    2. To evaluate over time the safety and tolerability of best medical practice with adjunctive VNS Therapy in patients with refractory seizures.


Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Minimum ages eligible for the E-103 study is 7 years for European sites and 12 years for sites in the US.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of patients with a diagnosis of refractory seizures that are treated with adjunctive VNS Therapy.

Criteria

Inclusion Criteria:

Patients enrolled in the study must meet all of the following criteria at Visit 1:

(Baseline) if Screening Incl/Excl is omitted:

  1. Patients must agree to be treated with VNS Therapy. The decision to treat with VNS Therapy must have been made independent of and prior to participation in the study.
  2. Patients participating at Sites located in Europe must be at least 7 years or older and whose epileptic disorder is dominated by partial seizures (with or without secondary generalization); patients participating at Sites located in the United States must be 12 years or older and have partial onset seizures or must follow the indication for use statement (for VNS Therapy) in the country of origin.
  3. Patient and/or caregiver must be able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
  4. Patient or legal guardian understands study procedures and voluntarily signs an informed consent and in the United States a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional policies. In the event that the patient is under the age of 18 the patient will also be required to sign an assent affirming their agreement to participate in research according to local IRB requirements. Similar authorization is required per EC requirements, or equivalent authority.

    Additional Continuation Criteria to be evaluated at Visit 2 (Baseline):

  5. Patient must be taking at least 1 anti-epileptic drug treatment and stable on said medications for at least 8 weeks (56 days)prior to baseline.
  6. Patient must have a minimum frequency of 3 seizures (excluding absence seizures, simple partial seizures and myoclonic jerks) per month (average over 2 months) prior to baseline; maximum frequency is 20 seizures per day.
  7. Patient must have no more than 4 weeks between seizures (over 2 months) prior to baseline.

Exclusion Criteria:

Patients with any of the following will not be eligible for enrollment:

  1. Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
  2. Patient is expected to require full body magnetic resonance imaging during the clinical study.
  3. Patient has a progressive neurological condition (e.g. brain tumor etc.).
  4. In the investigator's opinion, the inability of the patient, legal guardian or reluctance of the child to comply with the frequency of clinic visits during the treatment phase.
  5. In the investigator's opinion, the patient has a history of noncompliance for seizure diary completion.
  6. Patient is currently using an investigational device or pharmacologic medication not approved by either EU or US regulatory authority.
  7. Patient has had a previous VNS Therapy implant.
  8. In the investigator's opinion, the patient is suicidal.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281293

Contacts
Contact: Mark Bunker, PharmD 281-228-7223 Mark.Bunker@cyberonics.com

Locations
United States, Georgia
Emory Healthcare Recruiting
Atlanta, Georgia, United States, 30322
Contact: Melanee Newman, RN    404-778-4249    mnewma2@emory.edu   
Principal Investigator: Sandra Helmers, MD         
United States, Illinois
University of Illinois College of Medicine at Peoria Terminated
Peoria, Illinois, United States, 61656-1649
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Debra Brodfuehrer    502-813-6577    dlbrod01@louisville.edu   
Principal Investigator: Chris Shafer, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: James Carter    212-746-2474    jac3003@med.cornell.edu   
Principal Investigator: Steven Karceski, MD         
United States, Pennsylvania
University of Pennsylvania Withdrawn
Philidelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kelly Lowen    615-936-0209    kelly.m.lowen@Vanderbilt.Edu   
Principal Investigator: Bassel Abou-Khalil, MD         
United States, Texas
Dell Children's Medical Center of Central Texas Withdrawn
Austin, Texas, United States, 78723
Texas Children's Hospital Withdrawn
Houston, Texas, United States, 77030
Covenant Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Roy Hendley       hendleyr1@covhs.org   
Principal Investigator: Kalarickal Oommen, MD         
United States, Wisconsin
St. Luke's Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Jennifer Fink, MS    414-649-5097    jennifer.fink@aurora.org   
Principal Investigator: George Morris, MD         
Austria
Neurologische Abteilung Krankenhaus Rosenhügel Withdrawn
Wien, Austria
Belgium
UZ Gasthuisberg Recruiting
Leuven, Belgium
Contact: An Verstrepen    0032 16 34 38 45    an.verstrepen@uzleuven.be   
Principal Investigator: Lieven Lagae         
Germany
Epilepsieklinik Tabor - Ladeburger Straße 15 Recruiting
Berlin, Germany
Contact: Martina Steinke, R.N.    0049+3338 752401    m.steinke@epi-tabor.de   
Principal Investigator: Hans-Beatus Straub         
Albert-Ludwigs-Universität Freiburg Recruiting
Freiburg, Germany
Contact: Alena Trankle    +49 761 270 53660    alena.traenkle@uniklinik-freiburg.de   
Principal Investigator: Andreas Schulze-Bonhage         
Universitatsklinikum Schleswig-Holstein Campus Kiel Recruiting
Kiel, Germany
Contact: Birte Hackelberg    0049(0)431 597-8519    b.hackelberg@neurologie.uni-kiel.de   
Principal Investigator: Nicolas Lang         
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Irit Avisar    00972 353 07 002    irit.avisar@sheba.health.gov.il   
Principal Investigator: Dr. Bruria Ben Zeev         
United Kingdom
Foundation Trust Queen Elizabeth Hospital Birmingham Recruiting
Birmingham, United Kingdom
Contact: Nicole Toghill    0044 7775 715 108    nicole.toghill@uhb.nhs.uk   
Principal Investigator: Imad Soryal         
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Mark Bunker, PharmD Cyberonics, Inc.
  More Information

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01281293     History of Changes
Other Study ID Numbers: Epilepsy (E)-103, E-103
Study First Received: January 5, 2011
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cyberonics, Inc.:
V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes;

ClinicalTrials.gov processed this record on September 22, 2014