Episodic Migraine, Migraine, Migraine With Aura, Migraine Without Aura
Conditions
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.
Interventions
DEVICECoolStat active device
The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
DEVICECoolStat sham device
The CoolStat sham device will administer a sham flow of ambient air into the nostril.
Sponsors
CoolTech LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | 2 hours | 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 | 15 minutes | Number of subjects who fail to complete the full treatment session |
| Safety of the CoolStat Device | 24 hours | Number of participants with device-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Migraine-associated Symptoms | 2 hours | 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 |
| Pain Relief | 0 minutes | 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. |
| Use of Rescue Medication | 0 to 24 hours | The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session. |
| Pain Freedom | 2 hours | 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 |
| Relief From Migraine-associated Symptoms | 2 hours | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 87 subjects consented, 24 of whom were randomized to a treatment group. 63 subjects did not return to study sites for randomization during an active migraine attack during the 60-day enrollment period. 7 of those subjects reconsented for an additional 60- day enrollment period. Only two subjects who reconsented came to the clinic for randomization. 4 subjects were withdrawn post-consent because they became in eligible (3) or withdrew their consent (1).
Participants by arm
| Arm | Count |
|---|---|
| High Flow Treatment 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
CoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril. | 6 |
| Low Flow Treatment 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
CoolStat active device: The CoolStat active device will administer a therapeutic flow of dry air into the nostril. | 9 |
| Sham Flow Ambient Air 15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.
CoolStat sham device: The CoolStat sham device will administer a sham flow of ambient air into the nostril. | 9 |
| Total | 24 |
Baseline characteristics
| Characteristic | High Flow Treatment | Low Flow Treatment | Sham Flow Ambient Air | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 8 Participants | 22 Participants |
| Age, Continuous | 37.8 years STANDARD_DEVIATION 12.3 | 51.4 years STANDARD_DEVIATION 13.2 | 50.3 years STANDARD_DEVIATION 9.7 | 47.6 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 9 Participants | 8 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 7 Participants | 20 Participants |
| Region of Enrollment United States | 6 Participants | 9 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 3 / 6 | 3 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 6 | 0 / 9 | 0 / 9 |
Outcome results
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.
Time frame: 2 hours
Population: The primary analysis was based on a mixed logistic regression model using the variable Pain Relief without rescue medication at 2 hours post treatment as the outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Pain Relief | 3 Participants |
| Low Flow Treatment | Pain Relief | 4 Participants |
| Sham Flow Ambient Air | Pain Relief | 8 Participants |
Primary
Safety of the CoolStat Device
Number of participants with device-related adverse events
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Safety of the CoolStat Device | 3 Participants |
| Low Flow Treatment | Safety of the CoolStat Device | 3 Participants |
| Sham Flow Ambient Air | Safety of the CoolStat Device | 0 Participants |
Primary
Tolerability of the CoolStat Device
Number of subjects who fail to complete the full treatment session
Time frame: 15 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Tolerability of the CoolStat Device | 2 Participants |
| Low Flow Treatment | Tolerability of the CoolStat Device | 1 Participants |
| Sham Flow Ambient Air | Tolerability of the CoolStat Device | 0 Participants |
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
Time frame: 2 hours
Population: Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Freedom From Migraine-associated Symptoms | 3 Participants |
| Low Flow Treatment | Freedom From Migraine-associated Symptoms | 3 Participants |
| Sham Flow Ambient Air | Freedom From Migraine-associated Symptoms | 5 Participants |
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
Time frame: 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Pain Freedom | 0 Participants |
| Low Flow Treatment | Pain Freedom | 0 Participants |
| Sham Flow Ambient Air | Pain Freedom | 4 Participants |
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Pain Freedom | 1 Participants |
| Low Flow Treatment | Pain Freedom | 0 Participants |
| Sham Flow Ambient Air | Pain Freedom | 4 Participants |
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.
Time frame: 0 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Pain Relief | 0 Participants |
| Low Flow Treatment | Pain Relief | 3 Participants |
| Sham Flow Ambient Air | Pain Relief | 7 Participants |
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
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Pain Relief | 1 Participants |
| Low Flow Treatment | Pain Relief | 2 Participants |
| Sham Flow Ambient Air | Pain Relief | 5 Participants |
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.
Time frame: 2 hours
Population: Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Relief From Migraine-associated Symptoms | 4 Participants |
| Low Flow Treatment | Relief From Migraine-associated Symptoms | 6 Participants |
| Sham Flow Ambient Air | Relief From Migraine-associated Symptoms | 7 Participants |
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.
Time frame: 0 to 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Flow Treatment | Use of Rescue Medication | 4 Participants |
| Low Flow Treatment | Use of Rescue Medication | 8 Participants |
| Sham Flow Ambient Air | Use of Rescue Medication | 4 Participants |