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Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures

NCT01118455 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2014-06-26

Study results available
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Summary

This is a randomized study designed to compare long-term treatment outcomes in pediatric patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus anti-epileptic drugs (AEDs). Seizure reduction, quality of life measures, and side effect profiles will be evaluated. The results of this study will provide controlled comparative data to better guide physicians in determining the best overall treatment strategy for patients with seizures who have failed initial AED therapy.

Conditions

Interventions

DEVICE

Vagus Nerve Stimulation (VNS) Therapy

Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.

DRUG

Anti-Epileptic Drug (AED)

Subject has tried at least 2 appropriate AEDs tested to tolerance or to blood levels at upper end of the target range of which at least 2 had been tolerated at normal doses.

Sponsors & Collaborators

  • Cyberonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Bunker, PharmD · Cyberonics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • Austria
  • Belgium
  • Germany
  • 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 NCT01118455 on ClinicalTrials.gov