Purpose

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

Condition

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.

Recruiting Locations

Medstar Georgetown University Hospital
McLean, Virginia 22101
Contact:
Chris Gough
ccg46@georgetown.edu

More Details

NCT ID
NCT03716505
Status
Recruiting
Sponsor
ElectroCore INC

Study Contact

Rebecca Cadet
1-888-903-2673
rebecca.cadet@electrocore.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.