Last updated on December 2019

Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

Brief description of study

The purpose of the study is to investigate if the use of gammaCore Sapphire device reduces the number of migraines preventatively.

Detailed Study Description

The study is a prospective randomized, multi-center, double-blind, parallel, sham-controlled study, designed for comparison of two parallel groups, gammaCore-Sapphire (active treatment) and a sham (inactive) treatment.

The study period will begin with a four-week run-in period, during which there is no investigational treatment. The purpose of the run-in period will be to establish a baseline of the subject's headache/migraine history for longitudinal comparison.

The run-in period will be followed by a 12-week randomized period when the subjects will be randomized (1:1) to either active treatment or sham (inactive) treatment.

Subjects will dose themselves 3 times per day for 12 weeks.

Clinical Study Identifier: NCT03716505

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Mayo Clinic

Scottsdale, AZ United States
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Hartford HealthCare Headache Center

West Hartford, CT United States
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Diamond Headache Clinic

Chicago, IL United States
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StudyMetrix, LLC

Saint Peters, MO United States
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Clinvest Research

Springfield, MO United States
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Dent Neurologic Institute

Amherst, NY United States
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Island Neurological Associates

Plainview, NY United States
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Thomas Jefferson University

Philadelphia, PA United States
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Norton Neurology

Louisville, KY United States
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