This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
The CoolStat sham device will administer a sham flow of ambient air into the nostril.
Mayo Clinic
Scottsdale, Arizona, United States
Michigan State University
East Lansing, Michigan, United States
Atrium Health Neurosciences Institute
Charlotte, North Carolina, United States
Pain Relief
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the CoolStat treatment session.
Time frame: 2 hours
Tolerability of the CoolStat Device
Number of subjects who fail to complete the full treatment session
Time frame: 15 minutes
Safety of the CoolStat Device
Number of participants with device-related adverse events
Time frame: 24 hours
Pain Relief
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) immediately after the CoolStat treatment session.
Time frame: 0 minutes
Pain Relief
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 24 hours after the CoolStat treatment session without the use of rescue medication
Time frame: 24 hours
Pain Freedom
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the CoolStat treatment session without the use of rescue medication
Time frame: 2 hours
Pain Freedom
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 24 hours after the CoolStat treatment session without the use of rescue medication.
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Time frame: 24 hours
Relief From Migraine-associated Symptoms
The percentage of patients having a reduction in symptom severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-treatment session without the use of rescue medication.
Time frame: 2 hours
Freedom From Migraine-associated Symptoms
The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the end of the CoolStat treatment session without the use of rescue medication
Time frame: 2 hours
Use of Rescue Medication
The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.
Time frame: 0 to 24 hours