Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2020

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.

Interventions

  • 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).
  • 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.

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Safety and effectiveness of gammaCore Sapphire as a treatment for the prevention of a migraine during the double-blind period measured by Incidence of Unexpected Adverse Events.
    • Time Frame: 12 weeks
    • The primary outcome measurement for effectiveness is the difference between the active and sham treatment groups in the mean reduction in number of migraine days during the last 4 weeks of the 12-week double-blind period (versus during the 4-week run-in period).

Secondary Measures

  • Responder rate in the nVNS group compared to the sham group
    • Time Frame: Last 4 weeks of the 12 week double-blind
    • A subject who reports at least a 50% decrease in the number of migraine days during the last 4 weeks in the 12-week double-blind period
  • Mean reduction in the number of headache days
    • Time Frame: Last 4 weeks of the 12 week double-blind
    • Difference between the nVNS and sham treatment groups in mean reduction in the number of headache days during the last 4 weeks of the 12-week double-blind period
  • Mean reduction in days on which acute migraine medication
    • Time Frame: Last 4 weeks of the 12 week double-blind
    • Difference between the nVNS and sham treatment groups in the mean reduction in days on which acute migraine medication was taken during the last 4 weeks of the 12 week double-blind period

Participating in This Clinical Trial

Key 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

Key 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ElectroCore INC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Staats, MD, Study Director, Chief Medical Officer
  • Overall Contact(s)
    • Premium Study Team, 1-888-903-2673, info@electrocore.com

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