electroCore, Inc. announced the publication of a peer-reviewed paper, entitled Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial in Cephalalgia, the official journal of the International Headache Society (IHS). The paper reports the results of a randomized, double-blind, sham-controlled trial conducted at twenty-seven sites across the United States. Originally designed and powered to randomize 400 patients, the study was closed early due to COVID-19 after enrolling 231 subjects.

The results of the study showed a decrease in the number of monthly headache days of 4.6 vs. -3.0 for sham (p=0.05) with 44.87% of subjects in the gammaCore group having greater than a 50% reduction in the number of migraine days per month compared with 26.81% for the sham group (p=0.05). Quality of life, as measured by the HIT-6 (Headache Impact scale), improved by -4.9 points vs.

-2.3 for sham (p<0.05). In the subpopulation of patients diagnosed with migraine with aura, the number of headache days decreased by 5.5 days in the nVNS group compared with 2.7 in the sham group (p=0<0.05), a therapeutic gain of >100% compared to sham. These findings are consistent with previous reports on the mechanisms of action that suggest nVNS may be particularly effective in patients with migraine with aura.