Migraine Clinical Trial
Official title:
A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled Study of gammaCore® Non-invasive Vagus Nerve Stimulator (nVNS), for the Acute Treatment of Migraine
This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine attacks
Period 1: 4-week observational run-in period; no stimulation treatment. Subjects use standard
of care (SoC) medication to treat their migraine attacks, according to their individual
prescriptions.
Period 2: 4-week randomized/controlled period. After the run-in period, subjects are
randomized (1:1) to receive either an nVNS device or a sham device to treat up to 5 migraine
attacks.
Period 3: 4-week open-label (active treatment) period. After the randomized period, subjects
continue to the open-label period where all subjects receive an active gammaCore device to
treat up to 5 migraine attacks.
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