85% of patients achieved at least a 50% reduction in monthly migraine days using the eCOT-NS technology system, according to real-world, open-label analysis
TAMPA, FL, USA, June 14, 2022 /EINPresswire.com/ — Neurolief, a neurotechnology innovator, today announced new data released at the 64th Annual Scientific Meeting hosted by the American Headache Society (June 9-12th, 2022, Denver, CO).
The real-world, open-label analysis presents clinically meaningful data on the prevention of migraine, including responder rate, reduction in monthly migraine days and reduction in medication use for those with high-frequency episodic or chronic migraine. The eCOT-NS System is a wearable digital therapeutic neurostimulation system, intended to treat migraine and reduce the need for drug therapies.
“Migraines cause debilitating symptoms for days each month for millions of patients worldwide,” says Roni Sharon, MD, a board-certified neurologist and headache specialist, “These results are very encouraging as they may offer hope that patients with high-frequency episodic and chronic migraine will be able to better manage their migraine disease safely at home without medications or surgery.”
Neurolief’s eCOT-NS technology is the first external, combined occipital and trigeminal neurostimulation system (eCOT-NS) which applies a mild, electrical impulse to 6 major nerve branches in the head associated with migraine.
Poster 1: Spectrum of Response to Relivion MG in High-Frequency Episodic and Chronic Migraine Patients: Post Hoc Analysis of Patients Achieving ≥50% and ≥75% Response Rate (poster #: P-197)
• This post-hoc analysis included 33 of 38 subjects with high frequency episodic or chronic migraine who self-administered daily 20-minute treatments with Relivion MG for a 3-month period.
• 85% of patients achieved at least a 50% reduction in monthly migraine days, representing a decrease from 16.3 to 4.2 migraine days and a reduction in the acute medication days by 71.1%.
• 45.4% of patients achieved at least a 75% reduction in monthly migraine days, representing a decrease from 15.6 to 2.5 migraine days and a reduction in the acute medication days by 88.5%.
• No serious adverse events were reported.
Poster 2: Long-term Efficacy and Safety of External Combined Occipital and Trigeminal Nerve Stimulation in Migraine Prevention (poster #: LB-P-02)
• This post-hoc analysis included 26 subjects with high frequency episodic or chronic migraine who self-administered daily 20-minute treatments with Relivion MG for a 6-month period.
• The average number of monthly migraine days decreased by 65.3% from 15.3 days to 5.3 days, with data revealing that 85% of patients achieved at least a 50% reduction in migraine days.
• Consumption of daily acute medications decreased by 76.8%.
• One case of minor skin irritation was reported and self-resolved.
“This very promising real-world analysis allows us to move forward with clinical trials further exploring the potential use of the eCOT-NS technology for migraine prevention in patients with episodic and chronic migraine,” said Amit Dar, Neurolief's Co-founder and CTO. “The possibility to substantially reduce monthly migraine days with this newly developed technology would be life-changing for patients living with migraine.”
Relivion MG is cleared by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine for patients 18 years of age and older and has received CE Mark. Neurolief will pursue an expanded indication for the preventive treatment of episodic and chronic migraine.
For more information on Relivion MG, visit Relivion.com
Dedicated to bringing relief to patients suffering from chronic neurological and neuropsychiatric disorders, Neurolief is creating a digital therapeutics platform of wearable clinically proven neuromodulation solutions. This technology, which is made to be worn like a headset, is intended to offer highly effective, safe treatment options that work either as an adjunct to current pharmaceutical therapies or as a stand-alone alternative to these therapies. It is designed to concurrently neuromodulate major neural pathways in the head, and thereby affect brain regions that are involved in control and modulation of mood and pain.
Neurolief’s technology is currently used for patients with migraine, being studied for major depression and planned for future indications to include insomnia, ADHD and additional chronic pain and neuropsychiatric disorders. The company is based in Israel, with US operations in Tampa, FL and is made up of highly experienced professionals with a proven track record in neurosciences, neuromodulation technology and the neurotech devices industry.
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