MigraineNCT04936061
Transnasal Cooling for Migraine
A study testing CoolStat active device in people with Migraine and Episodic Migraine, run by CoolTech LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine, Episodic Migraine, Migraine With Aura
- What is being tested?
- CoolStat active device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Oct 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atrium Health Neurosciences Institute
Charlotte, North Carolina, 28207
Michigan State University
East Lansing, Michigan, 48824
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine
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.
- Conditions
- Migraine, Episodic Migraine, Migraine With Aura, Migraine Without Aura
- Being tested
- CoolStat active device, CoolStat sham device
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolStat active deviceDevice
The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
CoolStat sham deviceDevice
The CoolStat sham device will administer a sham flow of ambient air into the nostril.
| Study group | Role | What they receive |
|---|---|---|
| High flow treatment | Experimental | 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. Receives: Device: CoolStat active device |
| Low flow treatment | Experimental | 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. Receives: Device: CoolStat active device |
| Sham flow ambient air | Sham comparator | 15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack. Receives: Device: CoolStat sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Tolerability of the CoolStat Device
Number of subjects who fail to complete the full treatment session
Measured: 15 minutes
Safety of the CoolStat Device
Number of participants with device-related adverse events
Measured: 24 hours
Secondary outcomes (7)
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.
Measured: 0 minutes
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start14 Oct 2021
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoolTech LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nauman Tariq, MD, Principal investigator, Atrium Health Neurosciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936061
- Sponsor's protocol ID
- P-224011-0040
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2021
- Last updated
- 29 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT04936061
- Acronym / sponsor ID
- P-224011-0040
- Conditions
- Migraine, Episodic Migraine, Migraine With Aura, Migraine Without Aura
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CoolTech LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Posted 29 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High flow treatment | Experimental | Device: CoolStat active device15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. |
| Low flow treatment | Experimental | Device: CoolStat active device15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack. |
| Sham flow ambient air | Sham comparator | Device: CoolStat sham device15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoolStat active deviceThe CoolStat active device will administer a therapeutic flow of dry air into the nostril. | Device | High flow treatment, Low flow treatment |
| CoolStat sham deviceThe CoolStat sham device will administer a sham flow of ambient air into the nostril. | Device | Sham flow ambient air |
Primary outcome
Pain Relief
Time frame: 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
Time frame: 15 minutes
Number of subjects who fail to complete the full treatment session
Safety of the CoolStat Device
Time frame: 24 hours
Number of participants with device-related adverse events
7 secondary outcomes
Pain Relief
Time frame: 0 minutes
Pain Relief
Time frame: 24 hours
Pain Freedom
Time frame: 2 hours
Pain Freedom
Time frame: 24 hours
Relief From Migraine-associated Symptoms
Time frame: 2 hours
Freedom From Migraine-associated Symptoms
Time frame: 2 hours
Use of Rescue Medication
Time frame: 0 to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Migraine
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
RecruitingObservational study
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Migraine
RecruitingPhase 3
Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)
Post Traumatic Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nauman Tariq, MD principal investigator
Atrium Health Neurosciences Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoolStat active device in people with Migraine and Episodic Migraine, run by CoolTech LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.