NEW YORK, May 31, 2018 /PRNewswire/ -- The Cefaly® PREVENT medical device, approved by the U.S. Food and Drug Administration (FDA) for migraine prophylaxis in episodic migraine, was also successful in a recent trial for chronic migraine prevention.
Previous pilot and pivotal trials (PREMICE1) demonstrated the efficacy and safety of the neuromodulation with Cefaly® PREVENT for the prophylaxis of migraine attacks in episodic migraine and led to the FDA approval. The new trial was conducted on chronic migraine patients (i.e. patients suffering from at least 15 headache days per month) at the University of Colorado in Denver.
The enrolled patients had an average 19 migraine days per month, which was significantly reduced by 23% after 3-months of electroceutical treatment with the Cefaly PREVENT device. Other endpoints (headache episodes, headache days, cumulative hours of headache) were also significantly improved; very impressively, the consumption of anti-migraine medication was reduced by 31%. A sub-analysis was performed on a group of patients suffering from permanent headache, which is the most difficult category of migraine patients to treat, yet even in this category patients showed significant improvement with a reduction of 36% in oral anti-migraine medication. Based on these encouraging positive results CEFALY Technology intends to file a new submission to the FDA to obtain an extension of migraine prophylaxis to chronic migraine patients.
"We are very impressed by these positive results for chronic migraine prevention, especially with the reduction of anti-migraine medication. The overuse of medication is one of the first contributors to ongoing migraines, creating a chronic condition and these new results show that Cefaly is able to help patients break free from this cycle. The trial also showed that the category of patients with permanent headache can benefit greatly from the Cefaly treatment," said Dr. Pierre Rigaux, chief executive officer of CEFALY Technology. "We are very excited to submit this data to the FDA in order to obtain an extension of the indication for use."
About Migraine and Chronic MigraineMigraine is an extraordinarily prevalent neurological disease and the third most prevalent illness in the world, according to the American Migraine Foundation2. It's estimated that 39 million men, women and children in the U.S. are affected by migraines and 1 billion worldwide. Patients with migraine can be diagnosed with chronic migraine, which is characterized by 15 or more headache days per month for at least three months3. In the US, approximately 10% of patients with migraine have chronic migraine and anti-migraine medication overuse is the major cause of migraine chronification 4, 5
About CEFALY TechnologyCEFALY 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.
…1 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.
2 Migraine facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed May 30, 2018.
3 Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808
4 Migraine prevalence, disease burden, and the need for preventive therapy. Lipton RB, Bigal ME, Diamond M, et al. Neurology. 2007;68(5):343-349.
5 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.
Media Contact: Maria Coder[email protected]
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Previous pilot and pivotal trials (PREMICE1) demonstrated the efficacy and safety of the neuromodulation with Cefaly® PREVENT for the prophylaxis of migraine attacks in episodic migraine and led to the FDA approval. The new trial was conducted on chronic migraine patients (i.e. patients suffering from at least 15 headache days per month) at the University of Colorado in Denver.
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The enrolled patients had an average 19 migraine days per month, which was significantly reduced by 23% after 3-months of electroceutical treatment with the Cefaly PREVENT device. Other endpoints (headache episodes, headache days, cumulative hours of headache) were also significantly improved; very impressively, the consumption of anti-migraine medication was reduced by 31%. A sub-analysis was performed on a group of patients suffering from permanent headache, which is the most difficult category of migraine patients to treat, yet even in this category patients showed significant improvement with a reduction of 36% in oral anti-migraine medication. Based on these encouraging positive results CEFALY Technology intends to file a new submission to the FDA to obtain an extension of migraine prophylaxis to chronic migraine patients.
"We are very impressed by these positive results for chronic migraine prevention, especially with the reduction of anti-migraine medication. The overuse of medication is one of the first contributors to ongoing migraines, creating a chronic condition and these new results show that Cefaly is able to help patients break free from this cycle. The trial also showed that the category of patients with permanent headache can benefit greatly from the Cefaly treatment," said Dr. Pierre Rigaux, chief executive officer of CEFALY Technology. "We are very excited to submit this data to the FDA in order to obtain an extension of the indication for use."
About Migraine and Chronic MigraineMigraine is an extraordinarily prevalent neurological disease and the third most prevalent illness in the world, according to the American Migraine Foundation2. It's estimated that 39 million men, women and children in the U.S. are affected by migraines and 1 billion worldwide. Patients with migraine can be diagnosed with chronic migraine, which is characterized by 15 or more headache days per month for at least three months3. In the US, approximately 10% of patients with migraine have chronic migraine and anti-migraine medication overuse is the major cause of migraine chronification 4, 5
About CEFALY TechnologyCEFALY 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.
…1 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.
2 Migraine facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed May 30, 2018.
3 Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808
4 Migraine prevalence, disease burden, and the need for preventive therapy. Lipton RB, Bigal ME, Diamond M, et al. Neurology. 2007;68(5):343-349.
5 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.
Media Contact: Maria Coder[email protected]
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