Mi-Helper for Migraine

(CALM3 Trial)

Overseen By Joy Holland, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mi-Helper, Inc.

Must not be taking: Opioids, Barbiturates

Disqualifiers: Chronic pain, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

156 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, double-blind, sham-controlled, randomized, decentralized trial. This study aims to assess the safety and efficacy of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting. Adults aged 18 years to 70 years old with a diagnosis of migraine (with or without aura) for at least one year will be recruited for this study.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that your migraine preventive medication has not changed for 4 weeks before joining. If you are using opioid medications, you cannot participate.

What data supports the effectiveness of the treatment Mi-Helper for migraine?

The research on online digital assistance (ODA) for behavioral training in migraine suggests that while ODA is feasible and well-accepted, it did not show better improvements in migraine attack frequency or quality of life compared to behavioral training alone. This indicates that while supportive, the treatment's effectiveness in reducing migraine symptoms remains uncertain. ^{1 2 3 4 5}

Is Mi-Helper safe for use in humans?

The safety of migraine treatments, including novel medications and devices, has been reviewed, and they generally appear to be safe for managing migraines. However, specific safety data for Mi-Helper is not provided in the available research. ^{6 7 8 9 10}

Research Team

Jessica Ailani, MD

Principal Investigator

MedStar Georgetown Headache Center

Eligibility Criteria

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.

Inclusion Criteria

Willingness to comply with all study procedures and availability for the duration of the study

My migraines started before I was 50.

Lives in the contiguous United States

Exclusion Criteria

Known or suspected pregnancy

I have 15 or more headache days each month.

I haven't had Botox, barbiturates, or certain injections in my head or neck in the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Mi-Helper transnasal cooling device or a sham comparator for acute treatment of migraine

48 hours

At-home treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours

Treatment Details

Interventions

• Mi-Helper

Trial Overview 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.

Participant Groups

Group I: Group I (active treatment) Experimental Treatment 1 Intervention

10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes

Group II: Group II (sham) Placebo Group 1 Intervention

2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes

Who Is Running the Clinical Trial?

Mi-Helper, Inc.

Lead Sponsor

Trials

1

Recruited

160+

Findings from Research

The study involving 44 migraine patients demonstrated that online digital assistance (ODA) is feasible and well-accepted as a supportive tool for behavioral training (BT), with minimal technical issues and positive participant feedback.

However, the addition of ODA did not lead to significantly better outcomes in terms of migraine attack frequency or quality of life compared to those who only received BT, indicating that while ODA is useful, its effectiveness in enhancing BT results remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and preliminary effects of online digital assistance (ODA) for behavioral attack prevention in migraine. Kleiboer, A., Sorbi, M., Mérelle, S., et al.[2015]

This review emphasizes the importance of understanding the safety profiles of common acute migraine treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergot alkaloids, antiemetics, and newer options like gepants and ditans.

It provides strategies to mitigate risks, particularly cardiovascular and gastrointestinal concerns, and highlights the need for clinicians to balance efficacy with safety when selecting migraine treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety in Episodic Migraine Management in Adults Part 1: Acute Treatments. Orlova, YY., Mehla, S., Chua, AL.[2022]

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

Onabotulinumtoxin A is an effective treatment for chronic migraine, approved since 2010, and works by targeting the release of neurotransmitters and neuropeptides involved in headache mechanisms.

While onabotulinumtoxin A is associated with more treatment-related adverse events than a placebo, it has fewer side effects compared to the oral medication topiramate, indicating a relatively favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Onabotulinumtoxin A in Chronic Migraine: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Corasaniti, MT., Bagetta, G., Nicotera, P., et al.[2023]

Rimegepant significantly improves outcomes for migraine patients, including freedom from pain and pain relief at 2 hours, with odds ratios indicating strong efficacy compared to placebo.

The treatment shows sustained benefits at 24 hours and does not appear to increase the risk of adverse events, suggesting it is a safe option for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. Yang, C., Zhang, Y.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Utility and preliminary effects of online digital assistance (ODA) for behavioral attack prevention in migraine. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Assessment of migraine severity using the MIGSEV scale: relationship to migraine features and quality of life. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Migraine throughout the life cycle: treatment through the ages. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Establishing content validity for the migraine Global Impression Item (mGI-I) assessment: a modified single-item migraine symptom severity questionnaire. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Validity and reliability of the Migraine-Treatment Optimization Questionnaire. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Drug Safety in Episodic Migraine Management in Adults Part 1: Acute Treatments. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Onabotulinumtoxin A in Chronic Migraine: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Novel Migraine Treatments: A Review [2023]