MedTrace Logo

Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

NCT00522418 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2015-01-26

Study results available
· View outcomes & findings →

Summary

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

Conditions

Interventions

DEVICE

Vagal Nerve Simulation (VNS) Therapy

VNS Therapy + Best Medical Practice including anti-epileptic drugs

DRUG

Best Medical Practive

Best Medical Practice including anti-Epileptic Drugs

Sponsors & Collaborators

  • Cyberonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Phillippe Ryvlin, MD · Hopital Neurologique, Lyon, France

  • Sophie Leyman, MD · Cyberonics Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522418 on ClinicalTrials.gov