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Abstract Details

Transnasal Evaporative Cooling Device for Migraine: A Randomized Trial
Headache
P14 - Poster Session 14 (11:45 AM-12:45 PM)
2-010

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

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

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.

Authors/Disclosures
Larry Charleston, IV, MD, MSc, FAHS (Michigan State University College of Human Medicine)
PRESENTER
Dr. Charleston has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/AbbVie. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven Biopharmaceuticals. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LinPharma. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Haleon. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Charleston has a non-compensated relationship as a Associate Editor with Headache Journal: The Journal of Head and Face Pain that is relevant to AAN interests or activities. Dr. Charleston has a non-compensated relationship as a Board Member at Large with Alliance for Headache Disorders Advocacy that is relevant to AAN interests or activities. Dr. Charleston has a non-compensated relationship as a Board Member with Clinical Neurological Society of America that is relevant to AAN interests or activities.
Amaal J. Starling, MD, FAAN (Mayo Clinic) Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Starling has received personal compensation in the range of $0-$499 for serving as a Consultant for Med-IQ. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Everyday Health. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for WebMD. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Miller Medical. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eNeura.
Nauman Tariq, MD Dr. Tariq has received personal compensation for serving as an employee of NC neurological society .