BASKING RIDGE, N.J., April 26, 2017 /PRNewswire/ -- electroCore, a neuroscience and technology company dedicated to improving patient outcomes through technological advancement, announced today that "Non-invasive Vagus Nerve Stimulation for the Acute Treatment of Episodic and Chronic Cluster Headache: Findings from the Randomized, Double-blind, Sham-controlled ACT2 Study," was presented yesterday at the 69th American Academy of Neurology (AAN) Annual Meeting, being held April 22-28, 2017, in Boston, MA.
On behalf of the authors, including primary investigator, Peter Goadsby, MD, PhD, Professor of Neurology, King's College London and Director, NIHR-Wellcome Trust Clinical Research Facility, King's College Hospital, London, Dr. Ilse de Coo, MD, Leiden University Medical Centre presented the data from the ACT2 clinical trial (Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache), evaluating the use of gammaCore® (non-invasive vagus nerve stimulator) for the acute treatment of pain associated with episodic or chronic cluster headache (eCH or cCH, respectively). Results presented yesterday demonstrated that the proportion of all attacks that achieved pain-free status at 15 minutes (primary endpoint) was superior for those using gammaCore (47.5%) versus sham (6.2%; p < 0.01) in the eCH cohort. In the cCH cohort, no treatment difference was shown (gammaCore, 4.8%; sham, 12.9%). The eCH cohort also saw a significantly greater percentage of patients respond to non-invasive vagus nerve stimulation (nVNS; no or mild pain) at 15 minutes for ≥50% of their attacks (64.3%) versus sham (15.4%; p = 0.01).
The U.S. Food and Drug Administration released gammaCore on April 14, 2017 for the acute treatment of pain associated with eCH in adult patients.
The abstract presented yesterday was one of 21 accepted for the Emerging Science Session. Abstracts qualify for this program if key aspects of research were conducted after the October 24, 2016 abstract submission deadline, are new and of sufficient scientific importance to warrant expedited presentation and publication. To view the 2017 Emerging Science abstracts, please visit the AAN annual meeting website at https://www.aan.com/conferences/2017-annual-meeting/abstracts/.
gammaCore® is the first non-invasive, hand-held medical device applied at the neck that acutely treats the pain associated with episodic cluster headache in adult patients through the transmission of a mild electrical stimulation to the vagus nerve through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients as needed to provide relief for the treatment of pain associated with episodic cluster headache without the potential side effects associated with standard of care. When placed on a patient's neck over the vagus nerve, gammaCore stimulates the nerve's afferent fibers resulting in the reduction of pain.
gammaCore is approved in the U.S. for the acute treatment of pain associated with episodic cluster headache in adult patients. In the European Union, gammaCore is CE-Marked for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache, and hemicrania continua) and medication overuse headache in adults. gammaCore is also released/cleared, licensed, registered and/or approved in Australia, Canada, Colombia, Hong Kong, India, New Zealand, South Africa, and Vietnam. In Germany, gammaCore is distributed by Desitin.
About Cluster Headache
Cluster headache is a rare but extremely painful primary headache disorder characterized by recurring unilateral attacks.i The condition is the least common type of headache disorder, occurring in approximately 1 to 2 out of 1,000 individuals.i Cluster headache predominantly affects males, with symptoms typically manifesting by the age of 30.ii Frequently nicknamed "suicide headache" due to the severity of pain associated with their occurrence, cluster headache bouts occur rapidly and with variable frequency but often at the same time each year or day and are often more frequent at night.iii Those at greater risk of cluster headache include heavy smokers and those with a family history of the condition.i
electroCore LLC is a U.S.-based neuroscience and technology company dedicated to improving patient outcomes through technological advancement and focused on developing a non-invasive vagus nerve stimulation therapy (gammaCore) for the treatment of multiple conditions in neurology, inflammation, and metabolic syndrome. The company's initial target is 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.
For more information, visit electrocore.com.
electroCore and gammaCore are trademarks of electroCore LLC.
IMPORTANT SAFETY INFORMATION REGARDING GAMMACORE
- The safety and effectiveness of the gammaCore Noninvasive Vagus Nerve Stimulator has not been established in the acute treatment of chronic cluster headache.
- This device has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache.
- The long-term effects of the chronic use of the device have not been evaluated.
- Safety and efficacy of the gammaCore device has not been evaluated in the following patients, and therefore is NOT indicated for:
- Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric patients
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients should not use gammaCore if they:
- Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck.
- Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
Note: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.
i "Cluster Headache." The Migraine Trust. The Migraine Trust, n.d. Web. 30 Nov. 2016. https://www.migrainetrust.org/about-migraine/types-of-migraine/other-headache-disorders/cluster-headache/.
ii "Disease & Conditions: Cluster Headaches"; Cleveland Clinic. Cleveland Clinic, 2016. Web. 30 Nov. 2016 http://my.clevelandclinic.org/health/diseases_conditions/hic_Cluster_Headaches.
iii International Headache Society. Dodick. Cephalalgia. 2000;20:787. Rozen. Headache. 2012;52:99. Physician Interviews. ClearView Analysis.
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SOURCE electroCore LLC