Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- *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.
- 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.
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||November 2007|
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.
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|Study Director:||Carol C Base, RN, MS||Cyberonics, Inc.|