285
Participants
Start Date
January 31, 2016
Primary Completion Date
December 31, 2016
Study Completion Date
March 31, 2017
gammaCore-S
At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication.
gammaCore-S Sham
At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication.
University Aldo Moro, Ospedale Pediatrico, Bari
IRCCS Istituto delle Scienze Neurologiche di Bologna, Ospedale Bellaria, Bologna
University Hospital of Careggi, Florence
Fondazione IRCCS Istituto Neurologico C. Besta, Milan
"IRCSS National Neurological Institute C. Mondino Foundation", Pavia
S. Maria della Misericordia Hospital, Perugia
INM Neuromed IRCCS, Pozzilli
IRCCS San Raffaele Pisana, Rome
Sant'Andrea Hospital, Sapienza University of Rome, Rome
University of Turin, Turin
Lead Sponsor
ElectroCore INC
INDUSTRY