Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
|ClinicalTrials.gov Identifier: NCT00215215|
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : February 22, 2006
|Condition or disease||Intervention/treatment||Phase|
|Epilepsies, Partial||Device: Vagus Nerve Stimulation Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2005|
|Study Completion Date :||November 2007|
- *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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215215
Show 23 Study Locations
|Study Director:||Carol C Base, RN, MS||Cyberonics, Inc.|