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Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00215215
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : February 22, 2006
Sponsor:
Information provided by:
Cyberonics, Inc.

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date February 22, 2006
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
  • *Quality of Life in Epilepsy Questionnaire (QOLIE)
  • at baseline, Week 26 and Week 52.
  • *Patients will be asked to keep a daily record of their seizures in a seizure diary supplied by the investigational sites.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00215215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
  • The QOLIE at baseline, Week 26 and Week 52.
  • *Percentage Change in Seizure-Related Disability Assessment Scale (SERDAS)at baseline and Week 52 for each patient.
  • *Percentage Change in Hospital Anxiety and Depression Scale (HAD)at baseline and Week 52 for each patient.
  • *Over the course of the study, AED medications will be assessed.
  • *Patient Satisfaction Survey will be performed at Week 52.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
Official Title  ICMJE Post Marketing Study; Randomized, Parallel-Group Comparison of Treatment With Pharmacotherapy or Adjunctive Vagus Nerve Stimulation Therapy for Pharmacoresistant Partial Seizures: A Large Simple Effectiveness Trial
Brief Summary To compare outcomes over 12 months of treatment with antiepileptic drugs (AEDs) alone or vagus nerve stimulation (VNS) therapy plus AEDs in patients who have partial seizures refractory to at least two, but not more than five, AEDs.
Detailed Description Published data suggest that patients who continue to experience seizures after trials of two or three AEDs are unlikely to become seizure-free with further attempts at pharmacotherapy. Such patients may experience poor quality of life and functional outcomes from continuing seizures and the adverse effects associated with further attempts at pharmacotherapy. VNS is a non-pharmacologic treatment for epilepsy with well-established effectiveness as an adjunctive treatment (to AEDs) for partial seizures refractory to AEDs, but there are no randomized clinical trials comparing the effectiveness of adjunctive VNS therapy with further pharmacotherapy alone in such patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsies, Partial
Intervention  ICMJE Device: Vagus Nerve Stimulation Therapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 16, 2005)
360
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has a diagnosis of partial seizures with onset before age 50, and the patient’s prior electroencephalography and magnetic resonance imaging studies are consistent with the diagnosis of partial seizures.
  • Patient has at least 4 complex partial seizures, but less than 25 seizures (any type), per month during the 3 months preceding randomization; for the 8 weeks preceding randomization, the seizure frequency should be confirmed from a patient diary.
  • Patient has not had an adequate response to an adequate dosage of -- or was intolerant to -- a minimum of 2 different AEDs.
  • Patient has (in the investigator’s judgment) sufficient impairment from his/her epilepsy and/or epilepsy treatment that the potential benefits/risks of VNS therapy are warranted.
  • Patient must currently be receiving at least one AED, but not more than three AEDs, in a stable dosage regimen for at least one month before randomization.
  • Patient must be 12 years of age or older.
  • Patient must be able to provide reliable seizure counts and to complete the evaluations specified in the study procedures flow chart.
  • Patient must provide written informed consent, or legal guardian must give written permission and the minor provide written assent.

Exclusion Criteria:

  • Patient has a history (lifetime) of having received more than 5 different AEDs.
  • Patient has had a bilateral or left cervical vagotomy.
  • Patient currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
  • A VNS Therapy System implant would (in the investigator’s judgment) pose an unacceptable surgical or medical risk for the patient.
  • Patient is expected to require full body magnetic resonance imaging during the clinical study.
  • Patient has had a previous VNS Therapy System implant.
  • Patient has a previous neuroimaging study that demonstrates mesial temporal sclerosis, cortical dysplasia, or a suspected brain tumor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00215215
Other Study ID Numbers  ICMJE E-20
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Cyberonics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carol C Base, RN, MS Cyberonics, Inc.
PRS Account Cyberonics, Inc.
Verification Date February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP