Preventative use reduced mean attack frequency from 4.5 attacks every 24 hours to 2.6 after treatmentBASKING RIDGE, New Jersey: A twelve-month open-label study in the March issue of the journal Neurology, reports that electroCore’s non-invasive Vagus Nerve stimulation (nVNS) device, gammaCore, is practical and effective as an acute and preventative treatment in cluster headache. Seventy-nine percent 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 Professor Peter Goadsby1 and was conducted at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.
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 twenty-four hours to 2.6 after treatment.
Professor Peter 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 CEO of electroCore, commented: “The success of this pioneering study led to our large-scale randomized PREVA2 trial, which was presented at the International Headache meeting (EHMTIC) 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.
“Our many clinical trials continue to show that our hand held, vagus nerve stimulation device gammaCore is effective in helping patients prevent and treat cluster headache”.
gammaCore, which is presently seeking FDA 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 EU, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada.
electroCore, which is based in New Jersey, is dedicated to developing non-invasive Vagus Nerve Stimulation (nVNS) self-administered therapies for the treatment of multiple conditions in neurology, psychiatry, gastroenterology and respiratory fields. The company’s initial focus is on the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society.
electroCore, has raised more than $80 million from investors including Merck’s Global Healthcare Innovation fund.
References: 1 Director, NIHR-Wellcome Trust, Kings Clinical Research Facility, Professor of Neurology, King’s College London and a Professor in the Department of Neurology at University of California, San Francisco.
2 The PREVA randomised trial which is the largest trial ever carried out into cluster headache was conducted at ten sites across Europe with 97 patients enrolled.