Trial Outcomes & Findings for Transnasal Cooling for Migraine (NCT NCT04936061)
NCT ID: NCT04936061
Last Updated: 2023-09-29
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
2 hours
Results posted on
2023-09-29
Participant Flow
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 Only two subjects who reconsented came to the clinic for randomization. 4 subjects were withdrawn post-consent because they became in eligible (3) or withdrew their consent (1).
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transnasal Cooling for Migraine
Baseline characteristics by cohort
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: 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.
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.
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Pain Relief
|
3 Participants
|
4 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 15 minutesNumber of subjects who fail to complete the full treatment session
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Tolerability of the CoolStat Device
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNumber of participants with device-related adverse events
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Safety of the CoolStat Device
|
3 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 minutesThe 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.
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Pain Relief
|
0 Participants
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 24 hoursThe 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
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Pain Relief
|
1 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 hoursThe 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
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Pain Freedom
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 hoursThe 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.
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Pain Freedom
|
1 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis
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.
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Relief From Migraine-associated Symptoms
|
4 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis.
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
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Freedom From Migraine-associated Symptoms
|
3 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 0 to 24 hoursThe percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.
Outcome measures
| Measure |
High Flow Treatment
n=6 Participants
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.
|
Low Flow Treatment
n=9 Participants
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.
|
Sham Flow Ambient Air
n=9 Participants
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.
|
|---|---|---|---|
|
Use of Rescue Medication
|
4 Participants
|
8 Participants
|
4 Participants
|
Adverse Events
High Flow Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Flow Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham Flow Ambient Air
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Flow Treatment
n=6 participants at risk
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.
|
Low Flow Treatment
n=9 participants at risk
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.
|
Sham Flow Ambient Air
n=9 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Burning sensation in nostril
|
33.3%
2/6 • Number of events 2 • 24 hours
|
11.1%
1/9 • Number of events 1 • 24 hours
|
0.00%
0/9 • 24 hours
|
|
Nervous system disorders
Increased head pain
|
16.7%
1/6 • Number of events 1 • 24 hours
|
11.1%
1/9 • Number of events 1 • 24 hours
|
0.00%
0/9 • 24 hours
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • 24 hours
|
0.00%
0/9 • 24 hours
|
0.00%
0/9 • 24 hours
|
|
General disorders
Nasal congestion
|
0.00%
0/6 • 24 hours
|
11.1%
1/9 • Number of events 1 • 24 hours
|
0.00%
0/9 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place