Treatment with gammaCore also resulted in meaningful improvements in quality of life and a reduction in the use of traditional rescue medications such as injectable sumatriptan and oxygen. Cluster headache is a condition that affects approximately the same number of people as multiple sclerosis, and is considered by experts to be one of the most painful medical conditions known to medicine. GammaCore’s demonstrated effects represent a significant breakthrough in the care of patients with this debilitating condition.
More particularly, the Prevention and Acute Treatment of Chronic Cluster Headache (PREVA) randomized and open label trial data were presented in three poster presentations and at a breakout symposium on Saturday evening, highlighting the following key findings:
Dr. Charly Gaul, Director of the Migraine and Headache Clinic in Königstein, Germany, who was the principle investigator of the PREVA study, and presented the data from this study during the symposium, commented, “This study is one of the few well controlled, randomized studies of any preventative treatment for cluster headache. The ability of electroCore’s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.”
gammaCore is a revolutionary non-invasive vagus nerve stimulation (nVNS) therapy developed by US based healthcare company electroCore. The patient delivers the therapy by holding the device on the neck over the vagus nerve for 90 seconds (link to picture) which painlessly delivers a proprietary electrical signal that activates specific fibers in the vagus nerve bundle. This stimulates the production of inhibitory transmitters in the central nervous system, and reduces the over expression of the excitatory neurotransmitter glutamate, which has been implicated in a number of headache disorders.
The PREVA trial, which is part of the largest trial program ever carried out in cluster headache, was conducted at ten sites across Europe with 97 patients enrolled. Ninety-three were randomized to participate following the initial baseline data collection. Forty-five of the patients were randomly selected to use gammaCore plus their usual treatment and 48 to the best available standard of care. The baseline data collection period was two-weeks, followed by the four-week randomized phase. All the patients from both arms were asked to continue on active therapy for an additional four-week open label phase.
The dosing of the therapy used in the PREVA trial was three, 120-second stimulations, delivered at two time points during each day.
JP Errico, the Chairman and CEO of electroCore noted: “We are very pleased with the results of the PREVA study. Cluster headache has traditionally been a difficult condition to treat, and it has proven very challenging to prevent the patients from experiencing the attacks that disable them. This prevention trial, part of the largest program ever carried out in cluster patients, shows that our gammaCore therapy can help patients significantly reduce the number of these excruciatingly painful attacks.
“While the gammaCore therapy is presently available in Europe, with a physician’s authorization, under a CE mark covering the treatment and prevention of primary headaches, including both migraine and cluster headache, the PREVA data enable us to go forward and seek reimbursement on behalf of patients, so that it is widely available for the patients who so desperately need it. We are hopeful to receive the necessary approvals to enter the US in 2015.
“This study and the many other studies we are now running prove that nVNS therapy is an effective and safe treatment. We are continuing to explore the efficacy of nVNS in a range of related diseases and disorders.”
Notes to Editors: