Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-epileptic Drug Treatment in Children With Refractory Seizures

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by:
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01118455
First received: May 5, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Epilepsy
Other: Anti-epileptic drug (AED) therapy
Device: Vagus Nerve Stimulation (VNS) Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Randomised Trial to Assess the Efficacy and Safety of Adjunctive Vagus Nerve Stimulation (VNS) Versus Adjunctive New Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures

Resource links provided by NLM:


Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Proportion of Responders [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is the proportion of responders after one year of follow-up. Responders are defined as patients who have no new anti-epileptic drugs (AEDs) added or significant dose changes in baseline AEDs within one year of follow-up, along with a reduction in the percentage change in seizure frequency from baseline to the one month period prior to the one year follow-up of at least 50%.


Secondary Outcome Measures:
  • Percent change in seizure frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percent change in seizure frequency in patients who were previously treated with 2 to 5 anti-epileptic drugs (AEDs) versus patients previously treated with more then 5 AEDs.

  • Quality of Life in Epilepsy (QOLIE-31) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    To compare adjunctive Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to adjunctive anti-epileptic drug (AED) treatment in improving the quality of life of patients with seizures.

    The Quality of Life in Epilepsy Inventory (QOLIE-31) contains seven multi-item scales that tap the following health concepts: emotional well being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. Scores range from 0-100 with higher values indicating greater quality of life.


  • Adverse Event Profile [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To compare the safety of adjunctive Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to adjunctive anti-epileptic drug (AED) therapy in treating patients with seizures


Enrollment: 151
Study Start Date: October 2004
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: Anti-epileptic drug (AED) therapy Other: Anti-epileptic drug (AED) therapy

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Refractory seizures
  2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose;
  3. Having at least 3 appropriate AEDs left to try
  4. Having his/her current AED medication at an optimal dose at baseline
  5. At least three seizures per month (average over 2 months prior to admission), excluding absences.
  6. No more than four (4) weeks between seizures (over 2 months prior to admission)
  7. Age 17 years or less
  8. Having been evaluated for epilepsy surgery and resective surgery not felt indicated or patient/parents/legal guardian declined.
  9. Patient is a male or patient is a nonpregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control. Abstinence is an acceptable means of birth control
  10. Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional policies.

Exclusion Criteria:

  1. Having tried less then 2 AEDs tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal doses in the patient's lifetime
  2. A progressive neurological condition (e.g. brain tumor etc.)
  3. Inability of the parents or reluctance of the child to comply with the frequency of clinic visits during the treatment phase
  4. Patient has a history of noncompliance for seizure diary completion.
  5. Patient has taken an investigational drug within a period of five times the mean elimination half-life of the investigational drug plus two weeks.
  6. Patient is currently using another investigational device or drug.
  7. Patient is likely to require a whole body Magnetic resonance imaging (MRI) after VNS Therapy device implantation. (Refer to the Physician's Manual for the NCP Generator for additional information on the use of MRI.)
  8. Patient is currently receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation (Refer to Physician's Manual for the VNS (Vagus Nerve Stimulation) Therapy device for additional information on the contraindicated use of diathermy).
  9. Patient was previously enrolled in this or any other VNS Therapy device Study.
  10. Patient has an active peptic ulcer
  11. Patient has another unstable medical condition likely to precipitate seizures and make it difficult to evaluate to evaluate efficacy (e.g. diabetes)
  12. Patient has had a unilateral or bilateral cervical vagotomy.
  13. Patient is pregnant at the time of enrolment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118455

Locations
Austria
Medical University of Vienna - Vienna General Hospital (AKH)
Vienna, Austria
Belgium
CUB Hôpital Erasme
Brussels, Belgium
Germany
Kinderklinik der Justus-Liebig Universität
Giessen, Germany
University of Lübeck - Clinic for Paediatric Medicine
Lübeck, Germany
Sweden
University Hospital Lund
Lund, Sweden
University Children's Hospital
Uppsala, Sweden
United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
Royal Hospital for Sick Children
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom
Kings College Hospital
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Sir James Spence Institute - Royal Victoria Infirmary
Newcastle, United Kingdom
Queens's Medical Centre Nottingham
Nottingham, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom
Southampton Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Mark Bunker, PharmD Cyberonics, Inc.
  More Information

No publications provided

Responsible Party: Mark Bunker, PharmD, Sr. Director, Global Medical Affairs, Cyberonics, Inc
ClinicalTrials.gov Identifier: NCT01118455     History of Changes
Other Study ID Numbers: E-06
Study First Received: May 5, 2010
Last Updated: May 5, 2010
Health Authority: United Kingdom: Research Ethics Committee
Belgium: Institutional Review Board
Sweden: Institutional Review Board
Germany: Ethics Commission
Austria: Ethikkommission

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014