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.”
Source: Company Press Release.