Migraine Disorders Clinical Trial
Official title:
A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)
Verified date | September 2020 |
Source | ElectroCore INC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
Status | Completed |
Enrollment | 231 |
Est. completion date | September 9, 2020 |
Est. primary completion date | September 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dent Neurologic Institute | Amherst | New York |
United States | Michigan Head Pain & Neurological Institute (MHNI) | Ann Arbor | Michigan |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Montefiore Headache Center | Bronx | New York |
United States | The Research Center of Southern California | Carlsbad | California |
United States | Crescent City Headache and Neurology Center | Chalmette | Louisiana |
United States | Diamond Headache Clinic | Chicago | Illinois |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Ochsner North Shore Medical Center | Covington | Louisiana |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Summit Headache and Neurologic Institute, PC | Englewood | Colorado |
United States | NorthShore Ambulatory Care Center | Glenview | Illinois |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Norton Neurology | Louisville | Kentucky |
United States | Medstar Georgetown University Hospital | McLean | Virginia |
United States | University of Miami, Miller School of Medicine | Miami | Florida |
United States | West Virginia University Hospitals - Department of Neurology | Morgantown | West Virginia |
United States | NY Neurology Associates | New York | New York |
United States | Stanford University Medical Center Hoover Pavilion | Palo Alto | California |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Island Neurological Associates | Plainview | New York |
United States | Headache Neurology Research Institute | Ridgeland | Mississippi |
United States | StudyMetrix, LLC | Saint Peters | Missouri |
United States | UCSF Headache Center | San Francisco | California |
United States | California Medical Clinic for Headache | Santa Monica | California |
United States | Mayo Clinic | Scottsdale | Arizona |
United States | Clinvest Research | Springfield | Missouri |
United States | New England Institute for Neurology and Headache | Stamford | Connecticut |
United States | ClinPoint Trials LLC | Waxahachie | Texas |
United States | Hartford HealthCare Headache Center | West Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
ElectroCore INC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Responder rate in the nVNS group compared to the sham group | 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 | Last 4 weeks of the 12 week double-blind | |
Secondary | Mean reduction in the number of headache days | 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 | Last 4 weeks of the 12 week double-blind | |
Secondary | Mean reduction in days on which acute migraine medication | 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 | Last 4 weeks of the 12 week double-blind |
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