NEW YORK, June 18, 2018 /PRNewswire/ -- The Cefaly® ACUTE medical device, recently cleared by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine, is the subject of a large phase 3 clinical trial in the United States that is progressing rapidly.
Previous pilot and pivotal trials (ACME1) demonstrated the efficacy and safety of the Cefaly® ACUTE neuromodulation medical device for the acute treatment of migraine attacks and led to the FDA approval. An additional trial on migraine abortion (Rochester 2,3 ), identically designed to the trials testing abortive migraine medications, showed excellent efficacy outcomes for the Cefaly treatment, an electroceuticals, that outperformed published data on triptans as well as new medical drugs currently under investigation: Lasmiditan, Ubrogepant, Rimegepant. Now a phase 3 trial (TEAM study) is underway to confirm the superior efficacy and safety of Cefaly® ACUTE. As part of the trial, 11 research sites will recruit 600 patients. At present, nine sites are recruiting and have already enrolled 309 patients including 191 who have completed testing. The full completion of the trial is expected this October 2018.
"It's fantastic and the recruitment pace is impressive. It is always a big challenge to enroll patients in clinical phase 3 trials in a timely manner and to keep a steady recruitment pace," said Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology. "With the great organization of this trial we expect it to reach its completion in October, as it was ambitiously planned. We are eager to see the data analysis that is expected to demonstrate that Cefaly® ACUTE is the best acute treatment for migraine attacks and must be used as the first-line treatment."
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 Foundation4. 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 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 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.
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1 Acute Treatment of Migraine With e-TNS (ACME). U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT02590939
2 Abortive Treatment of Migraine With the Cefaly® Abortive Program Device. U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT03217968
3 PRNewswire: https://www.prnewswire.com/news-releases/migraine-abortion-trial-shows-positive-results-for-cefaly-acute-medical-device-300587430.html
4 Migraine facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed June 14, 2018.
5 Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33(9):629-808
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.
Media Contact: Maria Coder[email protected]
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Previous pilot and pivotal trials (ACME1) demonstrated the efficacy and safety of the Cefaly® ACUTE neuromodulation medical device for the acute treatment of migraine attacks and led to the FDA approval. An additional trial on migraine abortion (Rochester 2,3 ), identically designed to the trials testing abortive migraine medications, showed excellent efficacy outcomes for the Cefaly treatment, an electroceuticals, that outperformed published data on triptans as well as new medical drugs currently under investigation: Lasmiditan, Ubrogepant, Rimegepant. Now a phase 3 trial (TEAM study) is underway to confirm the superior efficacy and safety of Cefaly® ACUTE. As part of the trial, 11 research sites will recruit 600 patients. At present, nine sites are recruiting and have already enrolled 309 patients including 191 who have completed testing. The full completion of the trial is expected this October 2018.
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"It's fantastic and the recruitment pace is impressive. It is always a big challenge to enroll patients in clinical phase 3 trials in a timely manner and to keep a steady recruitment pace," said Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology. "With the great organization of this trial we expect it to reach its completion in October, as it was ambitiously planned. We are eager to see the data analysis that is expected to demonstrate that Cefaly® ACUTE is the best acute treatment for migraine attacks and must be used as the first-line treatment."
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 Foundation4. 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 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 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 Acute Treatment of Migraine With e-TNS (ACME). U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT02590939
2 Abortive Treatment of Migraine With the Cefaly® Abortive Program Device. U.S. National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT03217968
3 PRNewswire: https://www.prnewswire.com/news-releases/migraine-abortion-trial-shows-positive-results-for-cefaly-acute-medical-device-300587430.html
4 Migraine facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed June 14, 2018.
5 Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013; 33(9):629-808
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.
Media Contact: Maria Coder[email protected]
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SOURCE CEFALY Technology
