Back to resultsTransnasal Cooling for Migraine
Primary Purpose
Migraine, Episodic Migraine, Migraine With Aura
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CoolStat active device
CoolStat sham device
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- 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).
- Patient is between 18 and 80 years of age.
- Patient experiences 2 to 8 migraine attacks per month.
- Patient is in good reported general health, with no fever (<38.3C/101F).
- Patient has had diagnosis of migraine with or without aura over at least 1 year.
- Migraine onset before 50 years of age.
- Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
- Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
- Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
- has difficulty distinguishing his or her migraine attacks from tension-type headaches
- Patient has uncontrolled hypertension.
- Patient has a fever (≥38.3C / 101F).
- Patient has used opioid medication or barbiturates in the past month.
- Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
- Patient has 15 or more headache days per month.
- 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).
- Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
- Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
- Recurrent epistaxis or chronic rhinosinusitis.
- Recent facial trauma, sinus or intranasal surgery within the last 4 months.
- Known or suspected pregnancy.
- Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
Sites / Locations
- Mayo Clinic
- Michigan State University
- Atrium Health Neurosciences Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
High flow treatment
Low flow treatment
Sham flow ambient air
Arm Description
15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.
Outcomes
Primary Outcome Measures
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.
Tolerability of the CoolStat Device
Number of subjects who fail to complete the full treatment session
Safety of the CoolStat Device
Number of participants with device-related adverse events
Secondary Outcome Measures
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.
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
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
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04936061
Brief Title
Transnasal Cooling for Migraine
Official Title
A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoolTech LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Episodic Migraine, Migraine With Aura, Migraine Without Aura
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High flow treatment
Arm Type
Experimental
Arm Description
15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
Arm Title
Low flow treatment
Arm Type
Experimental
Arm Description
15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
Arm Title
Sham flow ambient air
Arm Type
Sham Comparator
Arm Description
15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.
Intervention Type
Device
Intervention Name(s)
CoolStat active device
Intervention Description
The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
Intervention Type
Device
Intervention Name(s)
CoolStat sham device
Intervention Description
The CoolStat sham device will administer a sham flow of ambient air into the nostril.
Primary Outcome Measure Information:
Title
Pain Relief
Description
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
Title
Tolerability of the CoolStat Device
Description
Number of subjects who fail to complete the full treatment session
Time Frame
15 minutes
Title
Safety of the CoolStat Device
Description
Number of participants with device-related adverse events
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Relief
Description
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
Title
Pain Relief
Description
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
Title
Pain Freedom
Description
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
Title
Pain Freedom
Description
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.
Time Frame
24 hours
Title
Relief From Migraine-associated Symptoms
Description
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
Title
Freedom From Migraine-associated Symptoms
Description
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
Title
Use of Rescue Medication
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Patient is between 18 and 80 years of age.
Patient experiences 2 to 8 migraine attacks per month.
Patient is in good reported general health, with no fever (<38.3C/101F).
Patient has had diagnosis of migraine with or without aura over at least 1 year.
Migraine onset before 50 years of age.
Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
has difficulty distinguishing his or her migraine attacks from tension-type headaches
Patient has uncontrolled hypertension.
Patient has a fever (≥38.3C / 101F).
Patient has used opioid medication or barbiturates in the past month.
Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
Patient has 15 or more headache days per month.
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).
Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
Recurrent epistaxis or chronic rhinosinusitis.
Recent facial trauma, sinus or intranasal surgery within the last 4 months.
Known or suspected pregnancy.
Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nauman Tariq, MD
Organizational Affiliation
Atrium Health Neurosciences Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Atrium Health Neurosciences Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Transnasal Cooling for Migraine
We'll reach out to this number within 24 hrs