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Completed

NCT Number: NCT03716505

Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

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

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Key information

Conditions

Migraine Disorders Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Disease Attributes Graft vs Host Disease Headache Disorders Headache Disorders, Primary Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gammaCore Sapphire active

Device

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).

gammaCore Sapphire Sham

Device

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

ElectroCore INC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2018
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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