Results of ACME trial of Cefaly with migraine published in Cephalalgia.- STX Medical.

Cephalalgia, the official peer-reviewed medical journal of the International Headache Society, has just published positive results of the American multicentric clinical trial ACME (ACute Migraine therapy with External trigeminal neurostimulation: randomized controlled trial) of Cefaly medical device, from STX Medical, in treating migraine attacks. The results of the study demonstrate the efficacy of the device in treating migraine attacks compared to placebo. The proportion of patients with pain relief after one-hour and 24-hours was significantly higher in the Cefaly group compared with the placebo group. One hour after the start of the treatment, 29% of the patients were pain-free in the active group and 6% in the placebo group. In the active group, 79% of patients achieved significant pain relief at one hour, compared to 39% in the placebo group. According to its makers, the device now has an efficacy similar to triptans, which have long been considered the most effective drugs for acute migraine but without the risks and side effects.

See: "Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial." Denise E Chou et al. Cephalalgia Published November 17, 2018 https://doi.org/10.1177/0333102418811573

Comment: Cefaly has been available in the U.S. since mid-March 2014, when the FDA approved the prescription-only, headband-like, device that uses tiny electrical impulses to stimulate the trigeminal nerve to reduce the frequency and intensity of migraines. A CE Mark was granted in 2013.