Efficacy and safety of kinetic oscillation stimulation in the nasal cavity for the treatment of acute migraine attacks: A randomized, placebo-controlled, double-blind investigation

Background Migraine attacks present a problem for patients who are unable to benefit from drug treatment. The Chordate System S020 delivers kinetic oscillation to the nasal mucosa, which is supposed to modulate the parasympathetic outflow involved in migraine pathophysiology. The objective of this clinical investigation was to evaluate the efficacy and safety of the Chordate System S020 in the treatment of acute migraine attacks. Methods In this randomized, placebo-controlled, double-blind, multicenter clinical investigation, participants were treated with the Chordate System S020 either in active or in placebo mode shortly after the onset of an acute, moderate to severe migraine attack. The primary endpoint was the proportion of participants whose headache pain improved to mild or no pain at 2 h after treatment start. The participants continued to report their response over the subsequent 48 h in a diary and were contacted by phone within 24 and 48 h after treatment. A final follow-up visit was performed 3 to 7 days after treatment. Results The study included 46 women and 5 men with a median age of 40.0 years. 42.3% of the participants who received active treatment ( N = 26) as compared to 32.0% of participants who received placebo treatment ( N = 25) met the primary endpoint of headache relief at 2 h ( p > .05). The odds ratio between active and placebo of the pain-free rate was 0.54 (95% CI 0.04–5.43) at 2 h and 1.78 (95% CI 0.09–112) at 24 and 48 h. More participants in the active vs placebo group improved numerically in nausea (50% vs 36%) and photophobia (42.3% vs 24%) at 2 h. Treatment with the Chordate System S020 was safe and well tolerated. Conclusions Treatment with the Chordate System S020 had no statistically significant effect on acute migraine headache relief.