EpilepsyV-COMPASNCT01281293
Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated
An observational study of Epilepsy, run by Cyberonics, Inc. at 20 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 124 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Jan 2011to 16 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of patients with a diagnosis of refractory seizures that are treated with adjunctive VNS Therapy.
Who may be able to join
- Patients enrolled in the study must meet all of the following criteria at Visit 1:
- (Baseline) if Screening Incl/Excl is omitted:
- 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.
- 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.
- Patient and/or caregiver must be able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
- 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.
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- Additional Continuation Criteria to be evaluated at Visit 2 (Baseline):
- 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.)
- 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.
- Patient must have no more than 4 weeks between seizures (over 2 months) prior to baseline.
Who cannot join
- Patients with any of the following will not be eligible for enrollment:
- Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
- Patient is expected to require full body magnetic resonance imaging during the clinical study.
- Patient has a progressive neurological condition (e.g. brain tumor etc.).
- 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.
- In the investigator's opinion, the patient has a history of noncompliance for seizure diary completion.
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- Patient is currently using an investigational device or pharmacologic medication not approved by either EU or US regulatory authority.
- Patient has had a previous VNS Therapy implant.
- In the investigator's opinion, the patient is suicidal.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United Kingdom8 sites
Birmingham Children's Hospital
Birmingham
Foundation Trust Queen Elizabeth Hospital Birmingham
Birmingham
Southmead Hospital Bristol
Bristol
Great Ormond Street Hospital for Children NHS Foundation Trust
London
National Hospital for Neurology & Neurosurgery - UCLH
London
John Radcliffe Hospital
Oxford
Salford Royal Hospital
Salford
Royal Hallamshire Hospital
Sheffield
United States7 sites
Emory Healthcare
Atlanta, Georgia, 30322
University of Louisville Hospital
Louisville, Kentucky, 40202
Covenant Hospital
Lubbock, Texas, 79410
St. Luke's Milwaukee
Milwaukee, Wisconsin, 53215
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Cornell University
New York, New York, 10065
University of Illinois College of Medicine at Peoria
Peoria, Illinois, 61656-1649
Germany3 sites
Epilepsieklinik Tabor - Ladeburger Straße 15
Berlin
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel
About this study
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.
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.
Read the 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.
- Conditions
- Epilepsy
- Keywords
- V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes;
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 27 months
Secondary outcomes (1)
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.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Jones, Study director, LivaNova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281293
- Sponsor's protocol ID
- Epilepsy (E)-103
- Other IDs
- E-103
- Acronym
- V-COMPAS
- Status last verified
- Sep 2019
- First submitted
- 5 Jan 2011
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01281293
- Acronym / sponsor ID
- V-COMPAS / Epilepsy (E)-103
- Conditions
- Epilepsy
- Keywords
- V-COMPAS; Vagus Nerve Stimulation Clinical Outcomes;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of patients with a diagnosis of refractory seizures that are treated with adjunctive VNS Therapy.
Key inclusion criteria (10 listed)
- 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.
- 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.
- Patient and/or caregiver must be able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
- 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.
- 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.)
Key exclusion criteria (9 listed)
- Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
- Patient is expected to require full body magnetic resonance imaging during the clinical study.
- Patient has a progressive neurological condition (e.g. brain tumor etc.).
- 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.
- In the investigator's opinion, the patient has a history of noncompliance for seizure diary completion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Efficacy and Safety
Time frame: 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Jones study director
LivaNova
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Cyberonics, Inc. at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, United States, Germany, Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-Year Clinical Follow-up (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.