Cooling to Alleviate Migraine #3 (NCT06874361) | Clinical Trial Compass
CompletedNot Applicable
Cooling to Alleviate Migraine #3
United States156 participantsStarted 2025-03-24
Plain-language summary
This is a prospective, double-blind, sham-controlled, randomized, decentralized trial. This study aims to assess the safety and efficacy of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting.
Adults aged 18 years to 70 years old with a diagnosis of migraine (with or without aura) for at least one year will be recruited for this study.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age of 18 to 70 years, inclusive, of either sex at birth.
✓. Lives in the contiguous United States.
✓. Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
✓. Diagnosis of migraine with or without aura for at least 1 year.
✓. Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
✓. Migraine onset before 50 years of age, self-reported during screening.
✓. Migraine preventive medication unchanged for 4 weeks prior to study enrollment.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion criteria
✕. Participant has difficulty distinguishing his or her migraine attacks from other types of headaches such as tension, exertion, cluster, hormonal or sinus headaches.
✕. Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
✕. Participant using any opioid medication at the time of screening.
✕. Participant has received Botox treatment, barbiturates, SPG block, nerve blocks or trigger point injections in the head or neck within the last 4 weeks of screening.