Two poster presentations at the American Headache Society (AHS) meeting in California, USA, reported the results of the sham controlled pilot study that examined the use of electroCore’s non-invasive vagus nerve stimulation therapy (nVNS) to prevent chronic migraine. The study met its endpoint of safety, and also demonstrated a reduction in the number of headache days per month for patients using the active device. The study further suggests that patients who remained on therapy for longer periods of time, may enjoy progressively larger decreases in headache days over the period they are on therapy.
Stephen Silberstein, professor of neurology at the Jefferson Medical College and director of the Jefferson Headache Centre comments: “In this pilot study we showed that nVNS was able to demonstrate an increasingly meaningful decrease in headache days in those patients who were treated with nVNS for a number of months. Our trial suggests that nVNS is a safe and effective alternative to drug therapies. I look forward to participating in larger studies in migraine to further confirm and expand on these findings.”
The study which ran over nine months at six sites across the US comprised a run-in period of one month, a double-blind comparison period of two months, and an open-label phase of six months during which all patients used electroCore’s gammaCore device on daily basis to reduce the occurrence of their chronic migraines. The 59 adult migraine patients who were enrolled in the study had to have had more than 15 headache days per month in the three months preceding the trial, in accordance with the ICHD definition of Chronic Migraine.
During the comparative period, the patients were randomised and given either an active gammaCore device or a sham device that appeared identical but did not stimulate the vagus nerve. Neither the patient, nor the physician, nor the clinical trial monitors were aware of which device each patient was given. The patients self-administered the treatment by placing the gammaCore device on the right sides of their necks, over their vagus nerves, three times daily. Each treatment consisted of two 90-second stimulations, five to ten minutes apart.
In the two month comparative phase, there was a decrease of 1.9 headache days per 28 days with three nVNS treated patients having more than a 50% decrease, and one having a 75% decrease in headache days. No sham control patients achieved a significant reduction. During the open label phase, the drop in headache days continued to grow, with patients originally randomised to the active therapy and remaining on therapy through the full six-month open label phase, experiencing more than an eight day drop in headache days per month. Among the entire group of patients remaining on therapy for the defined six months, 38% experienced a 50% reduction in headache days per month.
JP Errico founder and chief executive officer of electroCore comments, “We continue to be pleased by the clinical studies that consistently demonstrate nVNS therapy to be a safe, easy to use, preventative treatment that reduces the burden of severe headache for many patients. Although only a pilot study, these results confirms our intention to continue with larger scale studies in the prevention of migraine. We look forward to the full presentation of this data, and are continuing to explore the efficacy of nVNS in a range of related diseases and disorders.”
Data from all the 59 patients are included in the safety study. Twenty-six patients from the nVNS arm and 23 from the sham control arm completed the two-month comparative phase. No serious adverse events were reported.