electroCore’s Migraine Device Reduces Frequency of Headaches in Pilot Study

Migraine sufferers treated with gammaCore noninvasive vagus nerve stimulation had fewer headaches than patients treated with a sham device, devicemaker electroCore said Thursday in announcing results of a pilot clinical study.

Patients who remain on the nerve stimulation therapy for longer periods of time may have larger decreases in headache days, the company says. The device, which met the study’s safety endpoint, is intended for the prevention of chronic migraine.

The study enrolled 59 adult migraine patients, all of whom had more than 15 headache days per month in the three months preceding the trial. During a two month double blind comparison, patients were given either an active device or an identical-looking one that did not stimulate the vagus nerve. After a six-month open label phase, 38 percent of gammaCore patients showed a 50 percent reduction in headache days per month, the Basking Ridge, N.J., company says.

Additional studies are now underway, electroCore spokeswoman Jennifer Berman tells Device Daily Bulletin. The company also plans to test the device on epilepsy, irritable bowel syndrome and functional dyspepsia, she says.

The gammaCore is CE-marked and available in Europe and Canada. The company is in the process of seeking FDA approval, Berman adds. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.