Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated

Epilepsy Clinical Trial

— V-COMPAS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281293
• Other study ID #: Epilepsy (E)-103
• Secondary ID: E-103
• Status: Completed
• Start date: January 2011
• Est. completion date: August 16, 2018

Study information

• Verified date: September 2019
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 16, 2018
• Est. primary completion date: August 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven
Germany	Epilepsieklinik Tabor - Ladeburger Straße 15	Berlin
Germany	Albert-Ludwigs-Universität Freiburg	Freiburg
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Israel	Sheba Medical Center	Ramat Gan
United Kingdom	Birmingham Children's Hospital	Birmingham
United Kingdom	Foundation Trust Queen Elizabeth Hospital Birmingham	Birmingham
United Kingdom	Southmead Hospital Bristol	Bristol
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London
United Kingdom	National Hospital for Neurology & Neurosurgery - UCLH	London
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Salford Royal Hospital	Salford
United Kingdom	Royal Hallamshire Hospital	Sheffield
United States	Emory Healthcare	Atlanta	Georgia
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Covenant Hospital	Lubbock	Texas
United States	St. Luke's Milwaukee	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Cornell University	New York	New York
United States	University of Illinois College of Medicine at Peoria	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cyberonics, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-Year Clinical Follow-up	To follow the clinical course of patients with refractory seizures treated with adjunctive VNS Therapy over a two-year follow-up period.	27 months
Secondary	Efficacy and Safety	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.	27 months