Effectiveness Study Comparing Treatment With Drug(s) or Adjunctive VNS Therapy for Pharmacoresistant Partial Seizures
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215215
|Study Director:||Carol C Base, RN, MS||Cyberonics, Inc.|