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Transnasal Cooling for Migraine
NA trial testing CoolStat active device in Migraine in 24 participants. Terminated before completion.
| Lead sponsor | CoolTech LLC |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 14 October 2021 |
| Primary completion | 31 August 2022 |
| Estimated completion | 30 September 2022 |
| Sites | 3 locations across United States |
CoolTech LLC
Adults 18 to 80, any sex, with Migraine or Episodic Migraine. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 3 | |
| Low Flow Treatment | 4 | |
| Sham Flow Ambient Air | 8 |
Number of subjects who fail to complete the full treatment session
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 2 | |
| Low Flow Treatment | 1 | |
| Sham Flow Ambient Air | 0 |
Number of participants with device-related adverse events
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 3 | |
| Low Flow Treatment | 3 | |
| Sham Flow Ambient Air | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 0 | |
| Low Flow Treatment | 3 | |
| Sham Flow Ambient Air | 7 |
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
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 1 | |
| Low Flow Treatment | 2 | |
| Sham Flow Ambient Air | 5 |
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
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 0 | |
| Low Flow Treatment | 0 | |
| Sham Flow Ambient Air | 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 1 | |
| Low Flow Treatment | 0 | |
| Sham Flow Ambient Air | 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 4 | |
| Low Flow Treatment | 6 | |
| Sham Flow Ambient Air | 7 |
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
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 3 | |
| Low Flow Treatment | 3 | |
| Sham Flow Ambient Air | 5 |
The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.
| Group | Value | 95% CI |
|---|---|---|
| High Flow Treatment | 4 | |
| Low Flow Treatment | 8 | |
| Sham Flow Ambient Air | 4 |
Time frame: 24 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | High Flow Treatment | Low Flow Treatment | Sham Flow Ambient Air |
|---|---|---|---|---|
| Burning sensation in nostril | Skin and subcutaneous tissue disorders | — | — | — |
| Increased head pain | Nervous system disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Nasal congestion | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT04936061 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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