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
