To evaluate safety, tolerability, and optimal dose of a novel thermodynamic neuromodulation device--for acute treatment of migraine headache attacks.

Transnasal evaporative cooling may abort migraine headache attacks through modulation of the sphenopalatine ganglion.

A randomized, double-blind, study was conducted at 3 sites. 87 adults meeting the diagnostic criteria for episodic migraine with or without aura were enrolled. Subjects returned to clinic for a 15-minute treatment during a migraine headache attack. 24 subjects were randomized in a 1:1:1 ratio to three groups: 24 liters per minute (LPM), 18 LPM, and 6 LPM.  Pain levels and most bothersome symptoms (MBS) were recorded at baseline, 2-, and 24-hours post-treatment. The primary endpoint was pain relief (PR) at 2hrs. Secondary endpoints included tolerability, MBS relief and pain freedom (PF) at 2hrs.

Eighty-eight percent of the 6LPM group reported PR at 2hrs without rescue medication (woRM). 44% of the 6LPM group reported PF at 2hrs woRM. PR at 2hrs woRM was reported by 44% and 50% in the 18LPM and 24LPM group, respectively. MBS relief was reported at 2hrs by 77% in the 6LPM group. MBS relief at 2hrs was reported by 66% and 50% of the 18LPM and 24LPM groups, respectively. There were no adverse events in the 6LPM group. No adverse events reported in the 18LPM or 24LPM groups were serious or severe.

11% of the 6LPM group reported moderate intra-nasal discomfort during treatment. 33% percent and 83% of participants in the 18LPM and 24LPM groups, respectively, reported moderate or severe discomfort during treatment.  The study was terminated due to insufficient subject accrual rate.

Transnasal cooling at lower flow rates is effective and tolerable for treating acute migraine headache attacks. This data will help in dose ranging analysis to inform future studies.