231
Participants
Start Date
November 2, 2018
Primary Completion Date
September 9, 2020
Study Completion Date
September 9, 2020
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.
NY Neurology Associates, New York
Montefiore Headache Center, The Bronx
Island Neurological Associates, Plainview
Dent Neurologic Institute, Amherst
Thomas Jefferson University, Philadelphia
Medstar Georgetown University Hospital, McLean
West Virginia University Hospitals - Department of Neurology, Morgantown
University of Miami, Miller School of Medicine, Miami
Headache Neurology Research Institute, Ridgeland
Norton Neurology, Louisville
University Hospitals of Cleveland, Cleveland
Michigan Head Pain & Neurological Institute (MHNI), Ann Arbor
NorthShore Ambulatory Care Center, Glenview
Diamond Headache Clinic, Chicago
StudyMetrix, LLC, City of Saint Peters
Clinvest Research, Springfield
Crescent City Headache and Neurology Center, Chalmette
Ochsner North Shore Medical Center, Covington
ClinPoint Trials LLC, Waxahachie
University of Texas Southwestern Medical Center, Dallas
Summit Headache and Neurologic Institute, PC, Englewood
Mayo Clinic, Scottsdale
California Medical Clinic for Headache, Santa Monica
The Research Center of Southern California, Carlsbad
UCSF Headache Center, San Francisco
Stanford University Medical Center Hoover Pavilion, Palo Alto
New England Institute for Neurology and Headache, Stamford
Hartford HealthCare Headache Center, West Hartford
Beth Israel Deaconess Medical Center, Boston
Dartmouth-Hitchcock Medical Center, Lebanon
Lead Sponsor
ElectroCore INC
INDUSTRY