Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine

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

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.

Inclusion Criteria:

1. Age 18-65 years at the time of screening.

2. 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.

3. Onset of migraine headache occurred before age 50.

4. History of migraines for at least 1 year before screening.

5. The study subject reports at least 8 monthly migraine days during the screening period.

6. If subject is on a prophylactic migraine medication regimen:

   1. Reports stable medication regimen during the three months prior to screening.
   2. Able and willing to maintain medication regimen (no change in type, frequency or dose) from screening to end of follow-up.

7. 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.

8. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study.

9. Anticipated compliance with prescribed treatment and follow-up.

Exclusion Criteria:

1. Subject unable to distinguish between migraine headaches and other headache types.
2. Recently (12 months prior screening) undergone nasal or sinus surgery.
3. 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.
4. Previous (within 30 days prior to screening) and concurrent treatment with another investigational drug/s or device/s.
5. Subject is pregnant or lactating or planning to get pregnant during the duration of the study.
6. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation.
7. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.