Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

Migraine Clinical Trial

Official title:

A Prospective, Double-blind, Sham-controlled, Randomized Two-part Adaptive Clinical Trial to Assess the Safety, Efficacy, Tolerability, and Optimal Dose of the Mi-Helper Device for Acute Treatment of Episodic Migraine in an at Home Setting.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051604
• Other study ID #: COT-001
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: CoolTech LLC
• Contact: Joy Holland
• Phone: 5702288140
• Email: jholland[@]cooltechcorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, double-blind, sham-controlled, randomized two-part clinical trial with an adaptive design. This study aims to assess the efficacy, safety, tolerability, and the optimal dose of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting. This study will be conducted in two parts. The first part of this study aims to determine the most effective dose of Mi-Helper and the second part aims to evaluate the efficacy, safety, and tolerability of the most effective dose of the Mi-Helper device for the acute treatment of episodic migraine in adults. Adults aged 18 years to 65 years old with a diagnosis of episodic migraine (with or without aura) for at least one year (self-reported) will be recruited for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age of 18 to 65 years, inclusive of either sex at birth.

2. Lives in the contiguous United States.

3. Self-reported to be able to read and understand English sufficiently to provide informed consent.

4. Individual has had a diagnosis of episodic migraine with or without aura over at least 1 year, self-reported during screening.

5. Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.

6. Individual is in good reported general health at the time of screening.

7. Migraine onset before 50 years of age, self-reported during screening.

8. Migraine prophylaxis medication unchanged for 4 weeks prior to study enrollment.

9. Stated willingness to comply with all study procedures and availability for the duration of the study.

10. Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.

Exclusion Criteria:

1. Participant has difficulty distinguishing his or her migraine attacks from tension-type headaches.

2. Participant has 15 or more headache days per month reported via migraine eDiary and during screening.

3. Participant using any opioid medication at the time of screening.

4. Participant has received Botox treatment, barbiturates, supraorbital or occipital nerve blocks within the last 4 weeks of screening.

5. Participant lives at an altitude of 2000 meters or more above sea level.

6. Self-reported intolerance to intranasal therapy.

7. Self-reported recurrent epistaxis or chronic rhinosinusitis.

8. Self-reported sinus or intranasal surgery within the last 4 months of screening.

9. Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).

10. Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.

11. Prospective participant unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.

12. Self-reported diagnosis of alcohol or substance abuse disorder at the time of screening.

13. Participant with active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or complex regional pain syndrome (CRPS); or other pain syndrome like trigeminal neuralgia.

14. Participant with severe psychiatric conditions (such as major depressive episode, bipolar disorder, major depressive disorder, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.

15. Failure to adhere to or inability to complete Study App inputs and onboarding activities during the screening period. Participants who are not adherent during the screening period are not eligible for study entry.

16. Prospective participant has participated in a migraine study or any interventional clinical study within the 6 months prior to screening.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine
• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Device:
• Mi-Helper
The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.

Locations

Country	Name	City	State
United States	ObvioHealth	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
CoolTech LLC	ObvioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of rescue medication 2-24 post treatment.		24 hours
Other	Participants belief of which treatment is received.		24 hours
Primary	Pain relief at 2 hours post treatment	From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale	2 hours
Primary	Safety of the Mi-Helper device	Measured by incidence of adverse events	24 hours
Primary	Tolerability of the Mi-Helper device	Based on percent of participants who fail to complete the full treatment session	15 minutes
Secondary	Pain relief immediately post treatment	From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale	0 minutes
Secondary	Pain relief at 24 hours post treatment	From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale	24 hours
Secondary	Pain freedom immediately post treatment	A reduction of mild, moderate or severe pain at baseline to no pain.	0 minutes
Secondary	Pain freedom at 2 hours post treatment	A reduction of mild, moderate or severe pain at baseline to no pain.	2 hours
Secondary	Pain freedom at 24 hours post treatment	A reduction of mild, moderate or severe pain at baseline to no pain.	24 hours
Secondary	Relief from most bothersome symptom (MBS) immediately post treatment	From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale	0 minutes
Secondary	Relief from MBS at 2 hours post treatment	From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale	2 hours
Secondary	Relief from MBS at 24 hours post treatment	From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale	24 hours
Secondary	Freedom from MBS immediately post treatment	A reduction of mild, moderate or severe pain at baseline to none.	0 minutes
Secondary	Freedom from MBS at 2 hours post treatment	A reduction of mild, moderate or severe pain at baseline to none.	2 hours
Secondary	Freedom from MBS at 24 hours post treatment	A reduction of mild, moderate or severe pain at baseline to none.	24 hours