Migraine Disorders Clinical Trial
Official title:
A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)
The purpose of the study is to investigate if the use of gammaCore Sapphireâ„¢ device reduces the number of migraines preventatively.
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.
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