New Analysis of ACT Clinical Trial Program Highlights Efficacy and Safety of electroCore’s gammaCore® (non-invasive vagus nerve stimulator) in the Acute Treatment of Episodic Cluster Headache
- Data from Pooled Analysis of ACT1 and ACT2 To Be Presented in Late-Breaking Oral Session at Annual Scientific Meeting of the American Headache Society
Basking Ridge, NJ, June 8, 2017 – electroCore, a neuroscience and technology company dedicated to improving patient outcomes through technological advancement, today announced new data from the ACT (Non–Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache) clinical trial program demonstrating the safety and efficacy of gammaCore® (non-invasive vagus nerve stimulator) as an acute treatment for patients with episodic cluster headache (eCH) at the 59th Annual Scientific Meeting of the American Headache Society (AHS). Results of the pooled analysis, “Non-invasive Vagus Nerve Stimulation for Acute Treatment of Episodic and Chronic Cluster Headache: Pooled Analysis of Data From Two Randomized, Double-blind, Sham-Controlled Clinical Trials” (AHS Abstract #IOR3), will be presented on Saturday, June 10th as a late-breaking oral abstract.
"The findings from this pooled analysis of ACT1 and ACT2 are exciting,” said Professor Peter Goadsby, MD, PhD, Professor of Neurology, King’s College London and Director, NIHR-Wellcome Trust Clinical Research Facility, King’s College Hospital, London. “The data not only reinforces the safety and efficacy of gammaCore but also highlights some of the important advantages of non-invasive vagus nerve stimulation over existing treatment options, such as ease-of-use and the ability to be employed for multiple attacks a day.”
This new pooled analysis of data from ACT1 and ACT2 evaluated the safety and efficacy of gammaCore as an acute treatment for more than 250 patients with cluster headache (eCH or cCH). The proportion of patients who achieved mild or no pain at 15 minutes after treatment initiation for the first treated cluster attack (the ACT1 primary end point) was significantly greater in eCH patients treated with gammaCore versus sham for both ACT1 (34% vs. 11%; p = 0.01) and the pooled analysis (39% vs. 12%; p< 0.01), but not for ACT2 (50% vs. 15%; p = 0.07). The proportion of all treated attacks that achieved pain-free status at 15 minutes after treatment initiation (the ACT2 primary end point) was significantly greater in eCH patients treated with gammaCore versus sham for ACT1 (15% vs. 6%; p < 0.05), ACT2 (35% vs. 7%; p < 0.05), and the pooled analysis (24% vs. 7%; p < 0.01). There were no significant treatment differences for either of these end points in the total cluster headache population or the cCH population for ACT1, ACT2, or the pooled analysis. No serious adverse device effects were reported.
Additional results from the ACT2 trial, “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” (AHS Abstract #PS78), will be presented as a poster at the meeting. The trial found that the proportion of all attacks that achieved pain-free status at 15 minutes (primary end point) was superior for those using gammaCore versus sham (47.5% vs. 6.2%; p < 0.01) in the eCH cohort. In the cCH cohort, no treatment difference was shown (gammaCore, 4.8%; sham, 12.9%). Results from this trial were first presented during an Emerging Science Session at the American Academy of Neurology (AAN) Annual Meeting on April 25, 2017.
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. Commercial availability in the U.S. is expected early in the third quarter of 2017.
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
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 which may lead to a reduction of pain in patients.
gammaCore is released/cleared in the U.S. for the acute treatment of pain associated with episodic cluster headache in adult patients. gammaCore is currently in use outside of the U.S., including in the European Union, where it is CE-Marked.
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.
gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
electroCore, LLC is a U.S.-based neuroscience and technology company dedicated to improving patient outcomes through technological advancement and focused on developing non-invasive vagus nerve stimulation therapy 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.
[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.