Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
NCT ID: NCT03716505
Last Updated: 2020-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
231 participants
INTERVENTIONAL
2018-11-02
2020-09-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
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).
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
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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ElectroCore INC
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Staats, MD
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
The Research Center of Southern California
Carlsbad, California, United States
Stanford University Medical Center Hoover Pavilion
Palo Alto, California, United States
UCSF Headache Center
San Francisco, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
Summit Headache and Neurologic Institute, PC
Englewood, Colorado, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, United States
Hartford HealthCare Headache Center
West Hartford, Connecticut, United States
University of Miami, Miller School of Medicine
Miami, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
NorthShore Ambulatory Care Center
Glenview, Illinois, United States
Norton Neurology
Louisville, Kentucky, United States
Crescent City Headache and Neurology Center
Chalmette, Louisiana, United States
Ochsner North Shore Medical Center
Covington, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Michigan Head Pain & Neurological Institute (MHNI)
Ann Arbor, Michigan, United States
Headache Neurology Research Institute
Ridgeland, Mississippi, United States
StudyMetrix, LLC
City of Saint Peters, Missouri, United States
Clinvest Research
Springfield, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Dent Neurologic Institute
Amherst, New York, United States
NY Neurology Associates
New York, New York, United States
Island Neurological Associates
Plainview, New York, United States
Montefiore Headache Center
The Bronx, New York, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
ClinPoint Trials LLC
Waxahachie, Texas, United States
Medstar Georgetown University Hospital
McLean, Virginia, United States
West Virginia University Hospitals - Department of Neurology
Morgantown, West Virginia, United States
Countries
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References
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Najib U, Smith T, Hindiyeh N, Saper J, Nye B, Ashina S, McClure CK, Marmura MJ, Chase S, Liebler E, Lipton RB. Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial. Cephalalgia. 2022 Jun;42(7):560-569. doi: 10.1177/03331024211068813. Epub 2022 Jan 9.
Other Identifiers
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GM-US-10
Identifier Type: -
Identifier Source: org_study_id
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