Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

Trial ID or NCT#

NCT03716505

Status

recruiting iconRECRUITING

Purpose

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

Official Title

A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Between the ages of 18 and 75 years - Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria - Experiences between 8 to 20 headaches days per month (during the last 3 months), with at least 5 of them being migraine days - Onset of migraine at age 50 years or younger - Agrees to refrain from initiating or changing any prophylactic medications for indications other than migraine Key
Exclusion Criteria:
  1. - Concomitant medical condition that will require oral or injectable steroids during the study - Currently on a stable regime of more than 1 migraine preventative therapy - Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) - Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) - Known or suspected cerebrovascular disease - Previous cervical vagotomy - Currently implanted with an electrical and/or neurostimulator device - Been implanted with metal cervical spine hardware or has a metallic implant near the nVNS stimulation site - Known history or suspicion of secondary headache - Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 6 months - Currently takes simple analgesics or NSAIDs >15 days per month or triptans, ergots, or combined analgesics >10 days per month for headaches or other body pain - Currently takes prescription opioids more than 2 days per month for headaches or body pain - Failed an adequate trial (2 months or greater) of at least 3 classes of a drug therapy for migraine prevention - Surgery for migraine prevention - Undergone nerve block (occipital or other) in the head or neck within the last 3 months - Received Botox or CGRP mAb injections within the last 6 months - Pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control - Previously used gammaCore

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Contact

Stephanie Tran