TCH-003 study of Nerivio Migra meets primary endpoint in migraine control.- Theranica.

At the annual headache symposium of the American Headache Society, Theranica announces the results of TCH-003, a pivotal study of the Nerivio Migra, a novel non-invasive neuromodulation device for the acute treatment of migraine. The prospective, randomized, double-blind, sham-controlled, multi-center study evaluated the efficacy, safety and tolerability of the device on 252 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura. The study met its primary and almost all of its secondary and exploratory results with high statistical significance. On its primary endpoint of pain relief at 2 hours post-treatment the device demonstrated 66.7% response rate in the active arm vs. 38.8% in the placebo (p<0.0001).>

Statistical significance was obtained on 3 out of 4 secondary endpoints: On pain free at 2 hours post-treatment the response rate was 37.4% (active) vs. 18.4% (placebo) (p<0.004). on relief of the mbs most bothersome symptom out of phonophobia photophobia and nausea at 2 hours post-treatment the response rate was 46.3 active vs. 22.2 placebo p><0.001). on relief of both pain and the mbs at 2 hours post-treatment the response rate was 40.0 active vs. 15.2 placebo p><0.0005). regulatory submission for nerivio migra has been filed in the united states. once approved theranica plans to commercialize nerivio migra by end of 2019.>