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

Sponsor
Cyberonics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01281293
Collaborator
(none)
124
Enrollment
20
Locations
91.5
Actual Duration (Months)
6.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Vagus 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 or Disease Intervention/Treatment Phase

    Detailed Description

    Minimum ages eligible for the E-103 study is at least 7 years outside of the US, consistent with "Non-US" labeling and 12 years for sites in the US.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    124 participants
    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.
    Actual Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Aug 16, 2018
    Actual Study Completion Date :
    Aug 16, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Two-Year Clinical Follow-up [27 months]

      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

    1. Efficacy and Safety [27 months]

      To evaluate over time the efficacy of best medical practice with adjunctive VNS Therapy in patients with refractory seizures. To evaluate over time the safety and tolerability of best medical practice with adjunctive VNS Therapy in patients with refractory seizures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 not located in the US must follow the "Non-US" labeling and be at least 7 years or older and whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications; 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):

    1. 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. (Rescue medication may be allowed on a case-by case basis with Cyberonics approval.)

    2. 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.

    3. 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

    Locations

    Site City State Country Postal Code
    1 Emory Healthcare Atlanta Georgia United States 30322
    2 University of Illinois College of Medicine at Peoria Peoria Illinois United States 61656-1649
    3 University of Louisville Hospital Louisville Kentucky United States 40202
    4 Cornell University New York New York United States 10065
    5 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    6 Covenant Hospital Lubbock Texas United States 79410
    7 St. Luke's Milwaukee Milwaukee Wisconsin United States 53215
    8 UZ Gasthuisberg Leuven Belgium
    9 Epilepsieklinik Tabor - Ladeburger Straße 15 Berlin Germany
    10 Albert-Ludwigs-Universität Freiburg Freiburg Germany
    11 Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel Germany
    12 Sheba Medical Center Ramat Gan Israel
    13 Birmingham Children's Hospital Birmingham United Kingdom
    14 Foundation Trust Queen Elizabeth Hospital Birmingham Birmingham United Kingdom
    15 Southmead Hospital Bristol Bristol United Kingdom
    16 Great Ormond Street Hospital for Children NHS Foundation Trust London United Kingdom
    17 National Hospital for Neurology & Neurosurgery - UCLH London United Kingdom
    18 John Radcliffe Hospital Oxford United Kingdom
    19 Salford Royal Hospital Salford United Kingdom
    20 Royal Hallamshire Hospital Sheffield United Kingdom

    Sponsors and Collaborators

    • Cyberonics, Inc.

    Investigators

    • Study Director: Jason Jones, LivaNova

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cyberonics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01281293
    Other Study ID Numbers:
    • Epilepsy (E)-103
    • E-103
    First Posted:
    Jan 21, 2011
    Last Update Posted:
    Sep 23, 2019
    Last Verified:
    Sep 1, 2019
    Keywords provided by Cyberonics, Inc.
    V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes;
    Additional relevant MeSH terms:
    Epilepsy

    Study Results

    No Results Posted as of Sep 23, 2019