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Recruitment problems
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flow treatment | Experimental | 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. |
|
| Low flow treatment | Experimental | 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. |
|
| Sham flow ambient air | Sham Comparator | 15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolStat active device | Device | The CoolStat active device will administer a therapeutic flow of dry air into the nostril. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Tolerability of the CoolStat Device | Number of subjects who fail to complete the full treatment session | 15 minutes |
| Safety of the CoolStat Device | Number of participants with device-related adverse events | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nauman Tariq, MD | Atrium Health Neurosciences Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| Michigan State University |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Low Flow Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 2 hours |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation in nostril | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | CoolTech | 570-228-8140 | jholland@cooltechcorp.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2021 | May 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| CoolStat sham device | Device | The CoolStat sham device will administer a sham flow of ambient air into the nostril. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| East Lansing |
| Michigan |
| 48824 |
| United States |
| Atrium Health Neurosciences Institute | Charlotte | North Carolina | 28207 | United States |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Subjects provided their age at time of enrollment on screening questionnaire. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. |
| OG002 | 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. |
|
|
| Primary | Tolerability of the CoolStat Device | Number of subjects who fail to complete the full treatment session | Posted | Count of Participants | Participants | 15 minutes |
|
|
|
| Primary | Safety of the CoolStat Device | Number of participants with device-related adverse events | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis | Posted | Count of Participants | Participants | 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 | Most Bothersome Symptom scores at baseline and at 2 hours post treatment were compared for this analysis. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 0 to 24 hours |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | 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. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG002 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| Increased head pain | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Nasal congestion | General disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |