electroCore (ECOR) Reports Publication of gammaCore PREMIUM II Migraine Prevention Trial
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electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed article entitled “Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter , randomized, double-blind, fictitious PREMIUM II controlled trial ”in Headache, the official journal of the International Headache Society (IHS). The article reports the results of a randomized, double-blind, simulation-controlled trial conducted at twenty-seven sites across the United States. Originally designed and powered to randomize 400 patients, the study was prematurely closed due to COVID-19 after recruiting 231 subjects.
The results of the study showed a decrease in the number of monthly headache days of 4.6 versus -3.0 for the dummy treatment (p = 0.05) with 44.87% of subjects in the gammaCore group having a reduction of more than 50% in the number of migraine days. per month against 26.81% for the simulated group (p = 0.05). Quality of life, as measured by the HIT-6 (Headache Impact Scale), improved -4.9 points versus -2.3 for the sham (p100% versus sham These results are consistent with previous reports on mechanisms of action which 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 University of West Virginia and first author of the article commented: “We are pleased to have added to the data which helps suggest the types migraine patients who could possibly get the most benefit from nVNS. The safety and tolerability of nVNS is such that it can be used as a stand-alone or add-on therapy, depending on the patient’s needs, and its flexibility allows healthcare providers to consider it for many of their patients.
“We congratulate and thank all the investigators, site staff and subjects who conducted this study across the United States despite the challenges that have arrived with COVID-19,” commented Eric Liebler, senior vice president of the United States. neurology at electroCore. “With seven different indications from the FDA, gammaCore is safe and effective for many patients with primary headache, and the results of this study highlighting potential benefits in patients with migraine with aura are particularly compelling. “
The full publication is available on: https://journals.sagepub.com/doi/10.1177/03331024211068813