Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)
1 other identifier
interventional
231
1 country
30
Brief Summary
The purpose of the study is to investigate if the use of gammaCore Sapphireâ„¢ device reduces the number of migraines preventatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Typical duration for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
November 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2020
CompletedSeptember 11, 2020
September 1, 2020
1.9 years
October 10, 2018
September 10, 2020
Conditions
Keywords
Outcome Measures
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.
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).
12 weeks
Secondary Outcomes (3)
Responder rate in the nVNS group compared to the sham group
Last 4 weeks of the 12 week double-blind
Mean reduction in the number of headache days
Last 4 weeks of the 12 week double-blind
Mean reduction in days on which acute migraine medication
Last 4 weeks of the 12 week double-blind
Study Arms (2)
gammaCore Sapphire active
ACTIVE COMPARATORTreatment 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
SHAM COMPARATORTreatment 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
Interventions
GammaCore Sapphireâ„¢ 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 Sapphireâ„¢ has been approved for the treatment of headache, including migraine by the United States Food and Drug Administration (FDA).
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
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ElectroCore INClead
Study Sites (30)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
The Research Center of Southern California
Carlsbad, California, 92011, United States
Stanford University Medical Center Hoover Pavilion
Palo Alto, California, 94304, United States
UCSF Headache Center
San Francisco, California, 94115, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Summit Headache and Neurologic Institute, PC
Englewood, Colorado, 80113, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, 06905, United States
Hartford HealthCare Headache Center
West Hartford, Connecticut, 06107, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
Diamond Headache Clinic
Chicago, Illinois, 60642, United States
NorthShore Ambulatory Care Center
Glenview, Illinois, 60026, United States
Norton Neurology
Louisville, Kentucky, 40207, United States
Crescent City Headache and Neurology Center
Chalmette, Louisiana, 70043, United States
Ochsner North Shore Medical Center
Covington, Louisiana, 70433, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5400, United States
Michigan Head Pain & Neurological Institute (MHNI)
Ann Arbor, Michigan, 48104, United States
Headache Neurology Research Institute
Ridgeland, Mississippi, 39157, United States
StudyMetrix, LLC
City of Saint Peters, Missouri, 63303, United States
Clinvest Research
Springfield, Missouri, 65810, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
NY Neurology Associates
New York, New York, 10003, United States
Island Neurological Associates
Plainview, New York, 11803, United States
Montefiore Headache Center
The Bronx, New York, 10461, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
ClinPoint Trials LLC
Waxahachie, Texas, 75165, United States
Medstar Georgetown University Hospital
McLean, Virginia, 22101, United States
West Virginia University Hospitals - Department of Neurology
Morgantown, West Virginia, 26506, United States
Related Publications (1)
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.
PMID: 35001643DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Staats, MD
Chief Medical Officer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Two parallel groups, gammaCore®-Sapphire (active treatment) and a gammaCore®-Sapphire sham (inactive) treatment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2018
First Posted
October 23, 2018
Study Start
November 2, 2018
Primary Completion
September 9, 2020
Study Completion
September 9, 2020
Last Updated
September 11, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share