Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

Purpose

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

Condition

  • Migraine Disorders

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Two parallel groups, gammaCore®-Sapphire (active treatment) and a gammaCore®-Sapphire sham (inactive) treatment.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
gammaCore Sapphire active 		Treatment 3 times per day, every day for the 12-week treatment period Each of the 3 daily treatments comprises 2 consecutive 120-second stimulations on 1 side, ipsilateral (2 stimulations) to the side of predominate pain, upon waking, lunch time (i.e., between 11:00 AM and 2:00 PM), and prior to sleep, for a total of 6 stimulations per day
  • Device: gammaCore Sapphire active
    GammaCore Sapphire™ is a handheld, non-invasive, low voltage electrical device which stimulates the vagus nerve by producing weak 120 second electrical stimulation cycles that may help reduce, ease, lessen or stop your migraine symptoms. GammaCore Sapphire™ has been approved for the treatment of headache, including migraine by the United States Food and Drug Administration (FDA).
Sham Comparator
gammaCore Sapphire Sham 		Treatment 3 times per day, every day for the 12-week treatment period Each of the 3 daily treatments comprises 2 consecutive 120-second stimulations on 1 side, ipsilateral (2 stimulations) to the side of predominate pain, upon waking, lunch time (i.e., between 11:00 AM and 2:00 PM), and prior to sleep, for a total of 6 stimulations per day
  • Device: gammaCore Sapphire Sham
    The sham device is a hand-held portable device that appears identical to gammaCore Sapphire, in look, weight, visual and audible feedback, user application, and control. Like gammaCore Sapphire, the sham device is a multi-use device.

More Details

Status
Completed
Sponsor
ElectroCore INC

Study Contact

Detailed 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.