Transnasal Cooling for Migraine

NCT04936061 | Terminated Results DMC FDA Device

• 1 other identifier: P-224011-0040
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Migraine; Episodic Migraine; Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Pain Relief

  0 minutes

• Pain Relief

  24 hours

• Pain Freedom

  2 hours

• Pain Freedom

  24 hours

• Relief From Migraine-associated Symptoms

  2 hours

Study Arms (3)

High flow treatment

EXPERIMENTAL

15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.

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.

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.

Device: CoolStat sham device

Interventions

CoolStat active device DEVICE

The CoolStat active device will administer a therapeutic flow of dry air into the nostril.

High flow treatment; Low flow treatment

CoolStat sham device DEVICE

The CoolStat sham device will administer a sham flow of ambient air into the nostril.

Sham flow ambient air

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CoolTech LLC: lead

Study Sites (3)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Atrium Health Neurosciences Institute

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: CoolTech

jholland@cooltechcorp.com

570-228-8140

Study Officials

• Nauman Tariq, MD

  Atrium Health Neurosciences Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: October 14, 2021
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: September 29, 2023
• Results First Posted: September 29, 2023

Record last verified: 2023-09

Locations

US (3)