Condition category
Nervous System Diseases
Date applied
04/03/2013
Date assigned
26/04/2013
Last edited
26/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
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 follow for approximately 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?
The study started in January 2013 and study is expected to end by 2017.

Who is funding the study?
Cyberonics Europe BVBA

Who is the main contact?
Mr. Mark Bunker, Cyberonics Inc.
Clinical Department
+32 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 VNS 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.

Ethics approval

Ethics Board : CPP île de France 3, Approval Date : 05 December 2012, Reference: 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

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet
Cyberonics Europe BVBA
Clinical Department
+32 2 720 95 93

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary objective is to evaluate effectiveness of VNS Therapy in patients with drug resistant epilepsy treated with adjunctive VNS Therapy over a 2 year post-implant period in France.

Primary endpoint: response rate using a summary of participant seizure diary.

Secondary outcome measures

The secondary objectives are to assess 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.
Secondary endpoints:
1. Visit-wise Response Rate
2. Seizure frequency
3. Seizure severity
4. Health Status
5. Quality of Life

Overall trial start date

21/01/2013

Overall trial end date

30/12/2016

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

Other

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 inclusion criteria meet
The investigator should refer to the instructions for VNS Therapy use

Recruitment start date

21/01/2013

Recruitment end date

30/12/2016

Locations

Countries of recruitment

France

Trial participating centre

CH Sainte-Anne
Paris
75014
France

Sponsor information

Organisation

Cyberonics Europe BVBA (Belgium)

Sponsor details

Belgicastraat 9
Zaventem
1930
Belgium

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Cyberonics Inc. (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes