Belgium-based medical company CEFALY Technology revealed on Monday that its Cefaly ACUTE medical device has passed US Food and Drug Administration clearance (FDA) for the acute treatment of migraine, progressing rapidly into a large phase 3 clinical trial in the US.

Migraine is an extraordinarily prevalent neurological disease and patients with migraine can be diagnosed with chronic migraine, which is characterised by 15 or more headache days per month for at least three months.

This new phase 3 trial (TEAM study) is expected to confirm the superior efficacy and safety of Cefaly ACUTE, stated the company.

Under the company's 3 trial trial, 11 research sites will recruit 600 patients. At present, nine sites are recruiting and have enrolled 309 patients including 191 who have completed testing. The full completion of the trial is expected this October 2018.

According to the company, the 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. Another trial on migraine abortion, which was 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.