Clinical Trial

Cooling to Alleviate Migraine #3

Study acronym: CALM3
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-03-11; most recent amendment 2026-01-22.
Status change: Active, Not Recruiting → Completed 2026-01-22
Status change: Recruiting → Active, Not Recruiting 2025-12-03
Status change: Not Yet Recruiting → Recruiting 2025-08-04
Trial Details
NCT Number NCT06874361
Lead Sponsor Mi-Helper, Inc.
Conditions Migraine With or Without Aura, Migraine, Migraine Headache
Enrollment 156 participants
Start Date 2025-03-24
Primary Completion 2025-10-29 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-02-10