Benzinga | Jan 10, 2022 04:02PM EST

electroCore Highlights Publication Of PREMIUM II Trial Of gammaCore For Prevention Of Migraine

electroCore, Inc. (NASDAQ:ECOR), a commercial-stage bioelectronic medicine company, today 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.

Dr. Umer Najib, Associate Professor, Program Director of the Headache Medicine Fellowship Program at the West Virginia University and first author of the paper commented, "We are pleased to have added to the data that helps suggest the types of migraine patients who could likely benefit most from nVNS. The safety and tolerability of nVNS is such that it can be used as a stand-alone or adjunctive treatment, depending on the needs of the patient, and its flexibility allows health care providers to consider it for many of their patients."

"We congratulate and thank all of the investigators, site staff, and subjects who conducted this study throughout the United States despite the challenges that arrived with COVID-19," commented Eric Liebler, Senior Vice President of Neurology at electroCore. "With seven different indications from the FDA, gammaCore is safe and effective for many patients with primary headache, and the findings of this study highlighting the potential benefits in patients who have migraine with aura are particularly compelling."

The full publication is available at: https://journals.sagepub.com/doi/10.1177/03331024211068813