Clinical trial NCT04936061: Transnasal Cooling for Migraine
Official title: A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine
Episodic Migraine
Migraine With Aura
Migraine Without Aura
Lead sponsor: CoolTech LLC
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Meets the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction).
2. Patient is between 18 and 80 years of age.
3. Patient experiences 2 to 8 migraine attacks per month.
4. Patient is in good reported general health, with no fever (\<38.3C/101F).
5. Patient has had diagnosis of migraine with or without aura over at least 1 year.
6. Migraine onset before 50 years of age.
7. Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
8. Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
9. Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
10. Provision of signed and dated informed consent form.
11. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. has difficulty distinguishing his or her migraine attacks from tension-type headaches
2. Patient has uncontrolled hypertension.
3. Patient has a fever (≥38.3C / 101F).
4. Patient has used opioid medication or barbiturates in the past month.
5. Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
6. Patient has 15 or more headache days per month.
7. Patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (OTC) medications, prescription medications, or medical device).
8. Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
9. Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
10. Recurrent epistaxis or chronic rhinosinusitis.
11. Recent facial trauma, sinus or intranasal surgery within the last 4 months.
12. Known or suspected pregnancy.
13. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.

Primary outcomes:
measure: Pain Relief
timeFrame: 2 hours
measure: Tolerability of the CoolStat Device
timeFrame: 15 minutes
measure: Safety of the CoolStat Device
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Relief
timeFrame: 0 minutes
measure: Pain Relief
timeFrame: 24 hours
measure: Pain Freedom
timeFrame: 2 hours
measure: Pain Freedom
timeFrame: 24 hours
measure: Relief From Migraine-associated Symptoms
timeFrame: 2 hours
measure: Freedom From Migraine-associated Symptoms
timeFrame: 2 hours
measure: Use of Rescue Medication
timeFrame: 0 to 24 hours
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Charlotte
country: United States
facility: Atrium Health Neurosciences Institute
state: North Carolina
Study officials:
affiliation: Atrium Health Neurosciences Institute
name: Nauman Tariq, MD
role: PRINCIPAL_INVESTIGATOR
References: