Condition category
Nervous System Diseases
Date applied
04/03/2013
Date assigned
26/04/2013
Last edited
17/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Landre

ORCID ID

Contact details

CH Sainte-Anne
rue Cabanis 1
Paris
75014
France

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 measures

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

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

Sponsor information

Organisation

LivaNova Belgium N.V.

Sponsor details

Program Manager Neuromodulation
Ikaroslaan 83
Zaventem
1930
Belgium

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

17/01/2017: The following changes were made to the trial record: 1. The overall trial end date was changed from 30/12/2016 to 30/06/2017. 2. The sponsor/funder was changed from Cyberonics Europe BVBA (Belgium)/Cyberonics Inc. (USA) to LivaNova Belgium N.V. (Cyberonics merged with Sorin and became LivaNova).