Trials / Completed
CompletedNCT01281293
Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated
A Post Market, Long Term, Prospective, Observational, Multi-site Outcome Study to Follow the Clinical Course and Seizure Reduction of Patients With Refractory Seizures Who Are Being Treated With Adjunctive VNS Therapy.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 124 (actual)
- Sponsor
- Cyberonics, Inc. · Industry
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2018-08-16
- Completion
- 2018-08-16
- First posted
- 2011-01-21
- Last updated
- 2019-09-23
Locations
20 sites across 5 countries: United States, Belgium, Germany, Israel, United Kingdom
Source: ClinicalTrials.gov record NCT01281293. Inclusion in this directory is not an endorsement.