Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
- Conditions
- Migraine Disorders
- Interventions
- Device: gammaCore Sapphire activeDevice: gammaCore Sapphire Sham
- Registration Number
- NCT03716505
- Lead Sponsor
- ElectroCore INC
- Brief Summary
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description gammaCore Sapphire active 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 Sham 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
- Primary Outcome Measures
Name Time Method 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. 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 Outcome Measures
Name Time Method Mean reduction in the number of headache days 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 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
Responder rate in the nVNS group compared to the sham group 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
Trial Locations
- Locations (30)
Clinvest Research
🇺🇸Springfield, Missouri, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
West Virginia University Hospitals - Department of Neurology
🇺🇸Morgantown, West Virginia, United States
UCSF Headache Center
🇺🇸San Francisco, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Miami, Miller School of Medicine
🇺🇸Miami, Florida, United States
The Research Center of Southern California
🇺🇸Carlsbad, California, United States
Stanford University Medical Center Hoover Pavilion
🇺🇸Palo Alto, 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
NorthShore Ambulatory Care Center
🇺🇸Glenview, Illinois, United States
Hartford HealthCare Headache Center
🇺🇸West Hartford, Connecticut, United States
Diamond Headache Clinic
🇺🇸Chicago, Illinois, United States
Ochsner North Shore Medical Center
🇺🇸Covington, Louisiana, United States
Headache Neurology Research Institute
🇺🇸Ridgeland, Mississippi, United States
NY Neurology Associates
🇺🇸New York, New York, United States
Crescent City Headache and Neurology Center
🇺🇸Chalmette, Louisiana, United States
StudyMetrix, LLC
🇺🇸Saint Peters, Missouri, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Island Neurological Associates
🇺🇸Plainview, New York, United States
ClinPoint Trials LLC
🇺🇸Waxahachie, Texas, United States
Medstar Georgetown University Hospital
🇺🇸McLean, Virginia, United States
Norton Neurology
🇺🇸Louisville, Kentucky, United States
Montefiore Headache Center
🇺🇸Bronx, New York, United States
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Michigan Head Pain & Neurological Institute (MHNI)
🇺🇸Ann Arbor, Michigan, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States