Migraine
Conditions
Keywords
Migraine, Migraine prophylaxis / Preventive treatment, Neuromodulation, Intra-nasal mechanical stimulation, INMEST, Medical device, Chronic migraine, Episodic migraine, Headache disorders
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.
Interventions
DEVICEINMEST-treatment
Hand-held controller and catheter assembly for intra-nasal mechanical stimulation (INMEST), self-administered at home every second day for 6 weeks, first treatment under supervision.
Sponsors
Aurevia
Insamlingsstiftelsen för främjande av forskning avseende INMEST
Abilion Medical Systems AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Monthly Migraine Days | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean change in monthly headache days | Weeks 7-10 | Between-group comparison of the difference in mean change in monthly headache days from baseline. |
| Mean change in migraine intensity | Weeks 7-10 | Between-group comparison of the difference in mean change in migraine intensity from baseline. |
| Mean change in duration of migraine attacks | Weeks 7-10 | Between-group comparison of the difference in mean change in migraine attack duration (hours) from baseline. |
| Proportion of attacks requiring rescue medication | Weeks 7-10 | Between-group comparison of the proportion of migraine attacks requiring rescue medication. |
| Number of participants with ≥30% and ≥50% reduction in monthly migraine days | Weeks 7-10 | Between-group comparison of the proportion of subjects achieving ≥30% and ≥50% reduction in monthly migraine days. |
| Mean change in PROMIS-PI SF-6b | Weeks 7-10 | Between-group comparison of the difference in mean change from baseline in PROMIS-PI SF-6b scores. The raw scores are converted to standardized T-scores (range 0-100; mean = 50, SD = 10) based on the PROMIS calibration sample. Higher scores indicate greater pain-related interference. |
| Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ) | Weeks 7-10 | Between-group comparison of the difference in mean change from baseline in MSQ scores. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. |
| Adverse Events / Serious Adverse Events / Device Effects | Through study completion (14 or 20 weeks, depending on treatment group) | Number of treatment-related AEs, SAEs, ADEs, SADEs, and Unanticipated SADEs for the Walther System. |
| Device Deficiencies | Throughout the 6-week treatment period | Number of device deficiencies for the Walther System. |
| Mean change in Patient Global Impression of Severity (PGI-S) | Weeks 7-10 | Between-group comparison of the difference in mean change from baseline in PGI-S scores. Measured on a 7-point scale (1 = least severe, 7 = most severe), where higher values indicate greater severity. |
| Mean change in monthly migraine days | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 | Change from baseline in monthly migraine days within each group. |
| Mean change in migraine intensity (6-point severity scale) | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 | Change from baseline in migraine intensity within each group. Migraine intensity is assessed using a 6-point severity scale (1 = Very mild, 6 = Very severe), where higher scores indicate greater pain severity. |
| Proportion of migraine attacks requiring rescue medication | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 | Proportion of migraine attacks requiring rescue medication within each group. |
| Proportion of prescribed treatments completed | Throughout the 6-week treatment period | Compliance based on device usage logs or participant-reported treatment diaries. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device usability and user experience (combined questionnaires) | Throughout the 6-week treatment period | User-reported usability, ease of use, handling, and overall experience of the device during home use, assessed using two Device Usability Questionnaires. Questions include multiple 3- or 5-point scales, 0-10 scales, and yes/no responses. Higher scores indicate better usability or greater interest where applicable. |
| Symptom trends (Symptom Questionnaire) | Throughout the 6-week treatment period | Changes in symptoms potentially related to autonomic nervous system function, assessed using the Symptom Questionnaire at Visits 1-5. The questionnaire includes multiple items with 0-6 and 0-3 ordinal scales, yes/no responses, and other response formats. Higher scores indicate more severe symptoms. |
Countries
Sweden
Contacts
Primary ContactKarl-Johan Pantzar, MSc, MSc
Outcome results
None listed