Plain English Summary
Background and study aims
Vagus Nerve stimulation (VNS) Therapy has been CE marked for the treatment of epilepsy since 1994. This study is designed to assess clinical course and outcomes for patients diagnosed with partial or generalized seizures that are refractory (do not respond) to antiepileptic medication treated with standard of care including adjunctive VNS Therapy for patient with epilepsy.
Who can participate?
All patients who agree to be treated by VNS Therapy should take part to the study except if the patient declines participation.
What does the study involve?
If a patient agree to take part, he/she will be followed for about 27 months (2 visits pre-implant & 4 visits post-implantation at 6, 12, 18 and 24 months). During the study, the following items will be assessed: Seizure frequency, seizure severity, quality of life, health status and safety.
What are the possible benefits and risks of participating?
Patient may benefit from more frequent visits with their treating physician. There are no additional risks for patients in this study other than the loss of confidentiality and those risks associated with receiving a VNS Therapy device.
Where is the study run from?
The study will take place in 15 preselected hospitals across France
When is the study starting and how long is it expected to run for?
January 2013 to June 2017
Who is funding the study?
LivaNova Belgium N.V.
Who is the main contact?
Mr Wim Van Grunderbeek
Clinical Department
+32 (0)2 720 95 93
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
E-104
Study information
Scientific title
A post-market, long-term, prospective, observational, multi-site outcome study to assess the clinical course and seizure reduction of patients treated with adjunctive vagus nerve stimulation therapy in France
Acronym
E-104
Study hypothesis
This post-market observational study is designed to assess clinical course and outcome for patients diagnosed with partial or generalized seizures that are refractory to antiepileptic medications treated with standard of care including adjunctive VNS Therapy. Seizure frequency, seizure severity, quality of life, health status and safety will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of the VNS Therapy for patients with epilepsy. The data being collected is not for the purposes of confirmatory assessment.
The primary objective is to evaluate the effectiveness of VNS Therapy in patients with drug resistant epilepsy treated with adjunctive VNS Therapy over a 2 year post-implant period in France.
The secondary objectives are to assess the effectiveness endpoints, safety and tolerability of VNS Therapy in patients with epilepsy treated with adjunctive VNS Therapy over a 2 year post-implant period in France.
Ethics approval
Ethics Board: CPP île de France 3, 05/12/2012, ref: SC2995
Study design
Post-market long-term prospective observational multi-site study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Drug-resistant epilepsy
Intervention
Data from all investigative sites will be combined in the computation of summary statistics. Data will be summarized with respect to each of the parameters that include enrollment and disposition summaries, demographics and baseline disease characteristics. VNS Therapy effectiveness measures and safety measures.
If a patient agree to take part, he/she will be followed for approximately 27 months (2 visits pre-implant & 4 visits post-implantation at 6, 12, 18 and 24 months).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Response rate, measured using a summary of participant seizure diary at baseline (pre-implant)), and 6, 12, 18 and 24 months post implant
Secondary outcome measures
Measured at baseline (pre-implant)), and 6, 12, 18 and 24 months post implant:
1. Visit-wise response rate – percent (proportion) of patients who achieved a reduction of ≥ 50% in seizure frequency of all seizure types combined from baseline at each visit time-point after VNS device implant, measured by seizure frequency data in seizure diary
2. Seizure frequency of all seizures combined, measured using a seizure diary
3. Seizure severity, measured using the NHS3 scale
4. Health status, measured using EQ-5D and EQ-5D-Y
5. Quality of life, measured using Qolie-31-P and Qolie-AD-48
Overall trial start date
21/01/2013
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All newly patients implanted with a VNS device
2. Patients must have received the information letter and agreed that their data will be collected and transmitted to Cyberonics for analysis
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
150 patients. The enrollment period will end when 150 implanted patients have a least one follow-up assessment post-baseline
Participant exclusion criteria
Does not meet inclusion criteria
The investigator should refer to the instructions for VNS Therapy use
Recruitment start date
21/01/2013
Recruitment end date
31/03/2015
Locations
Countries of recruitment
France
Trial participating centre
Centre Hospitalier Sainte-Anne
Paris
-
France
Trial participating centre
Fondation Ophtalmologique Adolphe de Rothschild
Paris
-
France
Trial participating centre
Clinique de l'Europe
Rouen
-
France
Trial participating centre
Centre Hospitalier de Béthune
Béthune
-
France
Trial participating centre
Centre Hospitalier Régional Universitaire de Lille
Lille
-
France
Trial participating centre
Etablissement médical de la Teppe
Tain l'Hermitage
-
France
Trial participating centre
Hôpital Henri Gastaut
Marseille
-
France
Trial participating centre
Centre Hospitalier Universitaire de Dijon
Dijon
-
France
Trial participating centre
Centre Hospitalier Universitaire de Limoges
Limoges
-
France
Trial participating centre
Centre Hospitalier Universitaire de Toulouse
Toulouse
-
France
Trial participating centre
Centre Hospitalier Universitaire de Bordeaux
Bordeaux
-
France
Trial participating centre
Centre Hospitalier Universitaire de Nantes
Nantes
-
France
Trial participating centre
Centre Hospitalier Universitaire de Nîmes
Nîmes
-
France
Trial participating centre
Centre Hospitalier Universitaire d'Angers
Angers
-
France
Trial participating centre
Hôpitaux de Paris - Campus Necker
Paris
-
France
Funders
Funder type
Industry
Funder name
LivaNova Belgium N.V.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be available as of October 2017.
IPD sharing plan
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The data will be stored on a secured server at the sponsor’s site and won’t be accessible via a weblink.
Intention to publish date
01/10/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list