Clinical trial NCT06051604: Mi-Helper Transnasal Cooling for Acute Treatment of Migraine
Official title: A Prospective, Double-blind, Sham-controlled, Randomized 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episodic Migraine
Migraine With Aura
Migraine Without Aura
Migraine
Lead sponsor: CoolTech LLC
Sponsor class: INDUSTRY
Collaborators: name: ObvioHealth
First posted: 2023-09-25
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, double-blind, sham-controlled, randomized clinical trial . 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain relief at 2 hours post treatment
timeFrame: 2 hours
measure: Safety of the Mi-Helper device
timeFrame: 24 hours
measure: Tolerability of the Mi-Helper device
timeFrame: 15 minutes
Secondary outcomes:
measure: Pain relief immediately post treatment
timeFrame: 0 minutes
measure: Pain relief at 24 hours post treatment
timeFrame: 24 hours
measure: Pain freedom immediately post treatment
timeFrame: 0 minutes
measure: Pain freedom at 2 hours post treatment
timeFrame: 2 hours
measure: Pain freedom at 24 hours post treatment
timeFrame: 24 hours
measure: Relief from most bothersome symptom (MBS) immediately post treatment
timeFrame: 0 minutes
measure: Relief from MBS at 2 hours post treatment
timeFrame: 2 hours
measure: Relief from MBS at 24 hours post treatment
timeFrame: 24 hours
measure: Freedom from MBS immediately post treatment
timeFrame: 0 minutes
measure: Freedom from MBS at 2 hours post treatment
timeFrame: 2 hours
measure: Freedom from MBS at 24 hours post treatment
timeFrame: 24 hours
Other outcomes:
measure: Use of rescue medication 2-24 post treatment.
timeFrame: 24 hours
measure: Participants belief of which treatment is received.
timeFrame: 24 hours
Locations:
city: New York
country: United States
facility: ObvioHealth
state: New York
Study officials:
affiliation: ObvioHealth
name: Parth Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: