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Clinical Trials/NCT07279623
NCT07279623
Recruiting
Not Applicable

Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine - A Prospective, Randomized, Open Label, Delayed-Start Study to Evaluate the Safety and Performance of the Walther System

Abilion Medical Systems AB1 site in 1 country110 target enrollmentStarted: October 21, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Abilion Medical Systems AB
Enrollment
110
Locations
1
Primary Endpoint
Change in Monthly Migraine Days
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 18-65 years at the time of screening.
  • •The study subject must have a clinical diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-3), indicated by medical record shown by the subject.
  • •Onset of migraine headache occurred before age
  • •History of migraines for at least 1 year before screening.
  • •The study subject reports at least 8 monthly migraine days during the screening period.
  • •If subject is on a prophylactic migraine medication regimen:
  • •Reports stable medication regimen during the three months prior to screening.
  • •Able and willing to maintain medication regimen (no change in type, frequency or dose) from screening to end of follow-up.
  • •The study subject reports having understood and have signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
  • •Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.

Exclusion Criteria

  • •Subject unable to distinguish between migraine headaches and other headache types.
  • •Recently (12 months prior screening) undergone nasal or sinus surgery.
  • •Any severe diseases for which, in the opinion of the Investigator, participation would not be in the best interest of the subject or that can interfere with the performance, evaluation, and outcome of the clinical evaluation.
  • •Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s.
  • •Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
  • •The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
  • •The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.

Outcomes

Primary Outcomes

Change in Monthly Migraine Days

Time Frame: Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period)

Between-group comparison of the difference in mean change in monthly migraine days from the baseline assessment period (weeks 1-4) to Group A) Treatment performance period (weeks 7-10) and Group B) No treatment reference period (weeks 7-10).

Secondary Outcomes

  • Mean change in monthly headache days(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Mean change in migraine intensity(Weeks 7-10)
  • Mean change in duration of migraine attacks(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Proportion of attacks requiring rescue medication(Weeks 7-10)
  • Number of participants with ≥30% and ≥50% reduction in monthly migraine days(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Mean change in PROMIS-PI SF-6b(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ)(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Mean change in Patient Global Impression of Severity (PGI-S)(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Mean change in monthly migraine days(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Mean change in migraine intensity (6-point severity scale)(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Proportion of migraine attacks requiring rescue medication(Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20)
  • Proportion of prescribed treatments completed(Throughout the 6-week treatment period)
  • Adverse Events / Serious Adverse Events / Device Effects(Through study completion (14 or 20 weeks, depending on treatment group))
  • Device Deficiencies(Throughout the 6-week treatment period)

Investigators

Sponsor
Abilion Medical Systems AB
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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