Migraine Clinical Trial
Official title:
A Randomized, Multicentre, Double-blind, Parallel, Sham-controlled Study of gammaCore®, a Non-invasive Vagal Nerve Stimulator (nVNS), for Prevention of Episodic Migraine
A prospective, double-blind, randomized, sham-controlled, multicentre investigation.
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 observation for baseline
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.
The randomized period will be followed by a 24 week open label period, where the subjects in
the sham treatment group will switch in treatment assignment and receive a gammaCore®-R and
the gammaCore®-R will continue to receive an active treatment.
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