Actively Recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Led by Abilion Medical Systems AB · Updated on 2025-12-12
110
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
Sponsors
A
Abilion Medical Systems AB
Lead Sponsor
A
Aurevia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, randomized, open-label, delayed-start clinical investigation evaluating the safety and efficacy of the Walther System, a Class IIa investigational medical device delivering intra-nasal mechanical stimulation (INMEST), as a preventative treatment for migraine. A total of 110 adults (18-65 years) with a history of migraine will be randomized 1:1 into two groups: Group A (early treatment) and Group B (delayed treatment). The study includes baseline assessments, in-clinic device training, and home-based self-administered treatments every second day for six weeks. The primary outcome is the change in monthly migraine days during the primary treatment comparison period. Secondary outcomes include headache days, migraine intensity, duration, rescue medication use, patient-reported outcomes, device compliance, and safety. The study will be conducted at one site in Sweden.
CONDITIONS
Official Title
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years at the time of screening
- Clinical diagnosis of migraine without aura, migraine with aura, or chronic migraine according to ICHD-3
- Onset of migraine headache before age 50
- History of migraines for at least 1 year before screening
- Reports at least 8 monthly migraine days during screening
- If on prophylactic migraine medication, stable regimen for 3 months prior to screening
- Willing to maintain stable medication regimen throughout study
- Signed informed consent and willingness to comply with visits and assessments
- Women of childbearing potential agree to use reliable contraception during study
- Anticipated compliance with treatment and follow-up
You will not qualify if you...
- Unable to distinguish migraine headaches from other headache types
- Nasal or sinus surgery within 12 months prior to screening
- Severe diseases interfering with study participation or evaluation
- Treatment with another investigational drug or device within 30 days prior to screening
- Pregnant, lactating, or planning to become pregnant during study
- Cognitive incapacity or language barrier preventing understanding or cooperation
- Investigator considers participant unsuitable for other reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
INMEST-mottagningen Odenplan
Stockholm, Sweden, 11327
Actively Recruiting
Research Team
K
Karl-Johan Pantzar, MSc, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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