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Clinical Trial Summary

Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy since 1994. This post-market study is designed to follow the clinical course and outcomes for patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency, seizure severity, side effects burden, depressive symptoms, global impressions, and health care utilization will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of VNS Therapy for patients with refractory seizures who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected is not for the purposes of confirmatory assessment.


Clinical Trial Description

Minimum ages eligible for the E-103 study is at least 7 years outside of the US, consistent with "Non-US" labeling and 12 years for sites in the US. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01281293
Study type Observational
Source LivaNova
Contact
Status Completed
Phase
Start date January 2011
Completion date August 16, 2018

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