Transnasal Cooling for Migraine

Migraine Clinical Trial

Official title:

A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04936061
• Other study ID #: P-224011-0040
• Status: Terminated
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2023
• Source: CoolTech LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Device:
• CoolStat active device
The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
• CoolStat sham device
The CoolStat sham device will administer a sham flow of ambient air into the nostril.

Locations

Country	Name	City	State
United States	Atrium Health Neurosciences Institute	Charlotte	North Carolina
United States	Michigan State University	East Lansing	Michigan
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
CoolTech LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours
Primary	Tolerability of the CoolStat Device	Number of subjects who fail to complete the full treatment session	15 minutes
Primary	Safety of the CoolStat Device	Number of participants with device-related adverse events	24 hours
Secondary	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.	0 minutes
Secondary	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	24 hours
Secondary	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	2 hours
Secondary	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.	24 hours
Secondary	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.	2 hours
Secondary	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	2 hours
Secondary	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.	0 to 24 hours