New Trial Shows Cefaly is a Safe and Effective Preventive Treatment for Chronic Migraine

Researchers at the University of Colorado find a reduction in the frequency of migraine days and in overall acute medication for chronic migraineurs in trial using the Cefaly medical device

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CEFALY Technology

Jul 01, 2019, 09:00 ET

NEW YORK, July 1, 2019 /PRNewswire/ -- A new open-label trial, published by Birlea et al. in the peer-reviewed journal for the International Headache Society, Cephalalgia, concluded using the Cefaly medical device as a preventive treatment for chronic migraine headache is safe and effective.

A pilot trial¹, conducted at the University of Colorado, Anschutz Medical Campus in Aurora, Colorado, assessed 80 adult patients with a history of 15 or more headache days per month and meeting International Classification of Headache Disorder-3 beta² for chronic migraine. Of the 80 patients assessed, 73 were included in a baseline period and 58 entered the treatment period. Results analysis found headache days were reduced by an average of 3.12 days (16%) and acute medication intake decreased 30% (-8.11) during the third month of treatment, compared to the baseline. Patients were required to wear the Cefaly medical device at least once a day for 20 consecutive minutes. The results show an improvement in both: frequency of headache days and in overall acute medication intake when using the Cefaly medical device for 20-minutes daily. Also encouraging, Only 2 adverse effects were reported which could have been associated with use of the device, all of which were categorized as minor and fully reversible.

"We are continually excited by the positive findings in trials that demonstrate the safety and efficacy of Cefaly," said Dr. Mark Harman, US Medical Director with CEFALY Technology. "This means that patients with a history of persistent and debilitating headaches can benefit from our easy to use treatment, reduce their reliance on medication, and experience significantly less side effects."

Birlea et al. results echo findings in the previous trials (PREMICE³) that demonstrated the efficacy and safety of Cefaly for the prophylaxis of migraine attacks in episodic migraine in 2013 and RCT ACME⁴ (ACute Migraine therapy with External trigeminal neurostimulation) randomized controlled trial) implemented at Yale and Columbia Universities and at the Rowe Neurology Institute in Kansas last year, which also demonstrated efficacy of the Cefaly medical device in treating migraine attacks compared to placebo.

"We now have a device with efficacy rivaling triptans, a standard of migraine treatment for acute migraine but without the risks and side effects commonly associated with drugs," said Dr. Harman. "Some patients don't want to take medication and others simply cannot tolerate it. These trial results give Cefaly devices legitimacy as an adjunctive, complete, or alternative option to physicians and patients, that is significant for the migraine treatment field."

About Migraine and Chronic Migraine
Migraine is a prevalent neurological disease affecting 1 in 6 Americans. It is the 3^rd most prevalent illness in the world, according to the American Migraine Foundation⁵. It's estimated that 39 million men, women and children in the U.S. are affected by migraines and 1 billion worldwide. Many of these individuals are diagnosed with chronic migraine, characterized by 15 or more headache days per month for at least three months⁵. In the US, approximately 10% of patients with migraine have chronic migraine and anti-migraine medication overuse is the major cause of migraine chronification ^{6, 7}

About CEFALY Technology
CEFALY Technology is a Belgium-based company, with US offices based in Wilton, Connecticut, specializing in electronics for medical applications. It has developed external cranial stimulation technology for applications in the field of neurology; in particular for treating migraines. For more information, visit http://www.cefaly.us. Find Cefaly on Twitter: @Cefaly and on Facebook: http://www.facebook.com/CefalyEN.

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1 Efficacy and safety of external trigeminal neurostimulation in the prevention of chronic migraine: An open-label trial. Birlea M, Penning S, Callahan K, Schoenen J. Cephalalgia. 2019 June 18. https://doi.org/10.1177/2515816319856625

2 Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33(9):629-808

3 PREMICE: Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gérard P, Magis D. Neurology. 2013 Feb 19; 80(8):697-704.

4 Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2018 November 17: 0333102418811573.

SAGE. https://doi.org/10.1177/0333102418811573

5 Migraine facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts. Accessed June 26, 2019.

6 Migraine prevalence, disease burden, and the need for preventive therapy. Lipton RB, Bigal ME, Diamond M, et al. Neurology. 2007; 68(5):343-349.

7 Assessing Barriers to Chronic Migraine Consultation, Diagnosis, and Treatment: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Dodick DW, Loder EW, Manack Adams A, et al. Headache. 2016.

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SOURCE CEFALY Technology