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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01281293
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
LivaNova ( Cyberonics, Inc. )

Tracking Information
First Submitted Date January 5, 2011
First Posted Date January 21, 2011
Last Update Posted Date September 23, 2019
Actual Study Start Date January 2011
Actual Primary Completion Date August 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2011)
Two-Year Clinical Follow-up [ Time Frame: 27 months ]
To follow the clinical course of patients with refractory seizures treated with adjunctive VNS Therapy over a two-year follow-up period.
Original Primary Outcome Measures
 (submitted: January 20, 2011)
Clinical course of patients with refractory seizures treated with adjunctive VNS Therapy [ Time Frame: 27 months ]
To follow the clinical course of patients with refractory seizures treated with adjunctive VNS Therapy over a two-year follow-up period.
Change History Complete list of historical versions of study NCT01281293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 24, 2011)
Efficacy and Safety [ Time Frame: 27 months ]
  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.
Original Secondary Outcome Measures
 (submitted: January 20, 2011)
Evaluation over time of the Efficacy and Safety of best medical practice with adjunctive VNS Therapy in patients [ Time Frame: 27 months ]
  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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated
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.
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 10, 2017)
124
Original Estimated Enrollment
 (submitted: January 20, 2011)
600
Actual Study Completion Date August 16, 2018
Actual Primary Completion Date August 16, 2018   (Final data collection date for primary outcome measure)
Eligibility 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 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):

  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. (Rescue medication may be allowed on a case-by case basis with Cyberonics approval.)
  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.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Germany,   Israel,   United Kingdom,   United States
Removed Location Countries Austria
 
Administrative Information
NCT Number NCT01281293
Other Study ID Numbers Epilepsy (E)-103
E-103 ( Other Identifier: Cyberonics )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party LivaNova ( Cyberonics, Inc. )
Study Sponsor Cyberonics, Inc.
Collaborators Not Provided
Investigators
Study Director: Jason Jones LivaNova
PRS Account LivaNova
Verification Date September 2019