electroCore Announces Positive Top-Line Results from PREMIUM II Migraine Prevention Study
In the predefined modified intent to treat population (mITT; n=113), which was the designated primary analysis population for the study, patients using gammaCore™ nVNS had 3.1 less migraine days over the final four weeks of the 12 week double blind study period versus the four weeks of the run-in period as compared to a decrease of 2.3 migraine days in the sham group (primary endpoint; p=0.233).
Within the mITT population, 44.9% of the subjects using gammaCore™ nVNS had at least a 50% decrease in the number of migraine days compared to 26.8% for those receiving sham stimulation (secondary endpoint; p=0.048). Patients using gammaCore also reported a statistically significant decrease in migraine associated disability and improvement in their quality of life across all of the quality of life (QOL) endpoints in the study.
Of particular interest were the results in the predefined sub-population of patients diagnosed as having migraine with aura. In this group, patients using nVNS had 5.5 fewer headache days compared to 2.7 fewer headache days in the sham group (p=0.041). There were no serious adverse effects reported in the study, which is consistent with nVNS’ strong safety and tolerability profile.
Complete results of the study are expected to be published in early 2021 in a peer reviewed neurology journal. gammaCore™ received 510(k) clearance for the preventative treatment of migraine on
“The results of the
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. 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 FDA cleared in
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
- 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 an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- 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)
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the expected date of publication of complete study results from the