A twelve-month open-label study in the journal Neurology reports that electroCore’s non-invasive vagus nerve stimulation device, gammaCore, is practical and effective as an acute and preventative treatment in cluster headache. Seventy-nine per cent of patients who completed the trial (15 out of 19) reported an overall improvement in their condition.
The study into cluster headache, which is considered to be one of the most painful conditions known to medical science, was led by Peter Goadsby and was conducted at the Royal Free Hospital in London and the Beaumont Hospital in Dublin, Ireland.
Of the 25 patients enrolled 19 patients completed the study, 11 of whom had chronic cluster headache, and eight were classified as episodic. Seven of the chronic cluster patients were drug refractory having previously failed to respond to at least five different preventative agents. Of all acute attacks treated, 47% were aborted within an average of 11 minutes. Ten patients reduced their acute use of high flow oxygen by 55% with nine reducing triptan use by 48%. Preventative use of the gammaCore device resulted in a substantial reduction in estimated mean attack frequency from 4.5 attacks every 24 hours to 2.6 after treatment.
Goadsby who is lead author of the paper commented: “Cluster headache is a dreadful, extremely painful and disabling condition that can be very complex to manage. Given the unmet need for effective and safe treatments, we were excited to see the outcomes in these patients of an approach offering very considerable promise for future development.”
The treatment, which is self-administered by the patient for 120 seconds at home, involves placing the small, hand-held gammaCore device on the skin of the neck over the vagus nerve. In this study, patients carried out either two or three 120-second doses of stimulation twice per day—morning and evening—while acute attacks were treated with up to six doses at the onset of the attack. Patients reported no serious adverse events.
JP Errico, founder and chief executive officer of electroCore, commented: “The success of this pioneering study led to our large-scale randomised PREVA trial, which was presented at the International Headache meeting in September 2014. The results of that study demonstrated nearly the same efficacy in treating and preventing cluster headaches. The full results of the PREVA trial will shortly be published.”
gammaCore, which is presently seeking Food and Drug Administration approval for the treatment and prevention of cluster headache, currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in the EU, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada.