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July 10, 2013 -- There was great interest at the recent International Headache Congress in Boston in a poster on the results of an open label trial on non-invasive vagus nerve stimulation for the treatment of cluster headache. The trial sponsored by electroCore, one of the world leaders in the rapidly expanding field of electroceuticals, is part of the most comprehensive clinical trial programs in headache presently running.
The poster, authored by Drs. Peter Goadsby, Alex Nesbitt and Juana Marin reviewed their cohort of cluster headache patients who were successfully treated by nVNS over the past year.
electroCore’s presentation in Boston represented a subset of the data it previously presented on at the INS (International Neuromodulation Society) 11th World Congress in Berlin, which illustrated that nVNS may have meaningful clinical benefits, both in offering relief from acute cluster headaches as well as reducing the frequency of attacks.
The poster reported on an open-label trial run by the Royal Free London NHS Foundation Trust at two sites in the UK and Ireland and which included data from 21 patients, five of whom were followed for twelve months. It concluded that nVNS, as delivered by electroCore’s hand-held, home-use gammaCore device, appeared to be effective, safe and well-tolerated and useful for both acute and preventive treatment strategies of cluster headaches.
It further found that nVNS should be considered before surgically invasive neuro-stimulation, while the authors concluded that the data strongly supported the need for additional randomised studies of nVNS.
electroCore is conducting four randomized clinical trials, 2 of which are being conducted under an US, Investigational Device Exemption (IDE) for both migraine and cluster headaches.
Headaches are widely regarded as the world’s most common debilitating neurological disorder, with cluster headaches considered to be one of the most painful - if not the most painful of all - headache conditions.
Cluster headaches are normally treated with a combination of oxygen, various drugs as well as surgically invasive neuro-stimulation. Oxygen presents portability issues, however, while high doses of certain medication are contraindicated or may have unacceptable side effects while any invasive surgery can require the use of anaesthetics and have a range of possible complications.
All the patients who took part in the trial recommended electroCore’s non-invasive vagus nerve stimulation to other sufferers.
In the United States, only one product has been approved by the FDA for the treatment of acute cluster headaches. No products have been formally approved for reduction of cluster attacks.
• The research showed that on average, 47 per cent of the treated attacks were terminated within 15 minutes.
• There was also a reduction in the use of concomitant therapies, such as hi-flow oxygen and injectable triptans, which patients previously relied on.
• The research showed that nVNS is also useful for preventive treatment. On average, the number of attacks within a 24 hour period was cut in half.
• The trial detailed in this release was funded by the electroceutical healthcare company electroCore Medical LLC, a leader in its field. ElectroCore has discovered a novel technology which delivers very small, proprietary electrical signals to stimulate particular fibres in the vagus nerve which is believed to cause the release of inhibitory neurotransmitters in the brain stem, including GABA, serotonin and norepinephirine. These are believed to play a pivotal role in a wide range of conditions, including migraine and headache.
• ElectroCore’s gammaCore has regulatory approval in the European Union, South Africa, India, New Zealand, Australia, Colombia and Malaysia for the acute and/or prophylactic treatment of migraine, cluster headache and medication overuse headache, as well as in Canada for the treatment and prevention of cluster headache and for the treatment of migraines. The product is currently being launched through healthcare professionals in Canada, Germany, UK, and other parts of Europe. GammaCore is not approved for use in the United States, and is being studied under an Investigational exemption for both migraine and cluster headaches.
• ElectroCore was founded in 2005 and is based in New Jersey, USA.
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