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Device
Mi-Helper for Migraine (CALM3 Trial)
Indian Harbour Beach, FL
N/A
Waitlist Available
Led By Jessica Ailani, MD
Research Sponsored by Mi-Helper, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Migraine onset before 50 years of age, self-reported during screening
Age of 18 to 70 years, inclusive, of either sex at birth
Must not have
15 or more headache days per month reported via migraine eDiary and during screening
Received Botox treatment, barbiturates, SPG block, nerve blocks or trigger point injections in the head or neck within the last 4 weeks of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-24 hours
Summary
This trial will test a new cooling device called Mi-Helper for treating migraines at home. It will involve adults aged 18 to 70 with a diagnosis of migraines.
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Who is the study for?
Adults aged 18 to 70 with a migraine diagnosis for at least one year can participate. The trial is designed for those who experience migraines, with or without aura, and are seeking an acute treatment that can be used at home.Check my eligibility
What is being tested?
The Mi-Helper device, which provides transnasal cooling, is being tested to see if it's safe and effective in treating migraines when used at home. This study compares the real device to a sham (fake) version in a randomized setup where neither participants nor researchers know who gets which until after the results.See study design
What are the potential side effects?
Since this summary does not provide specific side effects of the Mi-Helper device, we can assume they might include discomfort or irritation from transnasal cooling but precise side effects would need clarification from detailed trial information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My migraines started before I was 50.
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I am between 18 and 70 years old.
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I have been diagnosed with migraine for at least 1 year.
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I own a smartphone with internet and can download an app.
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I have 2 to 8 migraine attacks a month, recorded in an eDiary.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have 15 or more headache days each month.
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I haven't had Botox, barbiturates, or certain injections in my head or neck in the last 4 weeks.
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I cannot tolerate nasal treatments.
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I often have nosebleeds or long-term sinus issues.
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I fully understand and can consent to the treatment.
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I suffer from ongoing chronic pain.
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I am currently taking opioid medication.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Adverse Events
Pain Freedom at 2 Hours Post Treatment
Secondary study objectives
Freedom from Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
Freedom from Most Bothersome Symptom (MBS) at Immediately Post Treatment
Freedom from Nausea Immediately Post Treatment
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (active treatment)Experimental Treatment1 Intervention
10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes
Group II: Group II (sham)Placebo Group1 Intervention
2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mi-Helper
2023
N/A
~180
Find a Location
Closest Location:SPRIM Pro· Indian Harbour Beach, FL· 845 miles
Who is running the clinical trial?
Mi-Helper, Inc.Lead Sponsor
Jessica Ailani, MDPrincipal InvestigatorMedStar Georgetown Headache Center