NCT06051604
Active, not recruiting
Not Applicable
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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Episodic Migraine
- Sponsor
- CoolTech LLC
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Pain relief at 2 hours post treatment
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age of 18 to 65 years, inclusive of either sex at birth.
- •Lives in the contiguous United States.
- •Self-reported to be able to read and understand English sufficiently to provide informed consent.
- •Individual has had a diagnosis of episodic migraine with or without aura over at least 1 year, self-reported during screening.
- •Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
- •Individual is in good reported general health at the time of screening.
- •Migraine onset before 50 years of age, self-reported during screening.
- •Migraine prophylaxis medication unchanged for 4 weeks prior to study enrollment.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.
Exclusion Criteria
- •Participant has difficulty distinguishing his or her migraine attacks from tension-type headaches.
- •Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
- •Participant using any opioid medication at the time of screening.
- •Participant has received Botox treatment, barbiturates, supraorbital or occipital nerve blocks within the last 4 weeks of screening.
- •Participant lives at an altitude of 2000 meters or more above sea level.
- •Self-reported intolerance to intranasal therapy.
- •Self-reported recurrent epistaxis or chronic rhinosinusitis.
- •Self-reported sinus or intranasal surgery within the last 4 months of screening.
- •Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).
- •Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.
Outcomes
Primary Outcomes
Pain relief at 2 hours post treatment
Time Frame: 2 hours
From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Safety of the Mi-Helper device
Time Frame: 24 hours
Measured by incidence of adverse events
Tolerability of the Mi-Helper device
Time Frame: 15 minutes
Based on percent of participants who fail to complete the full treatment session
Secondary Outcomes
- Pain relief immediately post treatment(0 minutes)
- Pain relief at 24 hours post treatment(24 hours)
- Pain freedom at 2 hours post treatment(2 hours)
- Pain freedom at 24 hours post treatment(24 hours)
- Freedom from MBS immediately post treatment(0 minutes)
- Freedom from MBS at 24 hours post treatment(24 hours)
- Relief from most bothersome symptom (MBS) immediately post treatment(0 minutes)
- Pain freedom immediately post treatment(0 minutes)
- Freedom from MBS at 2 hours post treatment(2 hours)
- Relief from MBS at 2 hours post treatment(2 hours)
- Relief from MBS at 24 hours post treatment(24 hours)
Study Sites (1)
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