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NCT01281293 · ClinicalTrials.gov registry record

Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated

A clinical trial, sponsored by Cyberonics.

Completed
Registry status
124
Enrollment target

NCT01281293 is a clinical trial that has completed, run by Cyberonics. The registered enrollment target is 124 participants.

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The verdict

NCT01281293 has completed, sponsored by Cyberonics.

COMPLETED
Registry status
124 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2011-01
Est. Completion 2018-08-16

Sponsor

Cyberonics

15 total trials

What the Registry Record Tells You About NCT01281293

The ClinicalTrials.gov registry entry for NCT01281293 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cyberonics, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01281293 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01281293 about?

NCT01281293 is a clinical study titled "Vagus Nerve Stimulation Clinical Outcomes Measured Prospectively in Patients Stimulated". 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 ...

What is the current status of trial NCT01281293?

This trial is currently completed. The enrollment target is 124 participants. The study started on 2011-01. Estimated completion is 2018-08-16.

Who is sponsoring clinical trial NCT01281293?

This trial is sponsored by Cyberonics, which has 15 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.