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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-25-05-052936 | Registry Identifier | Swedish Clinical Trials Registry |
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| Name | Class |
|---|---|
| Aurevia | INDUSTRY |
| Insamlingsstiftelsen för främjande av forskning avseende INMEST | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Early Start | Active Comparator | Subjects undergo a 4-week baseline assessment (weeks 1-4), then receive active treatment with the Walther System every second day for 6 weeks (weeks 5-10). The first treatment is performed under supervision at the clinic, and subsequent treatments are self-administered at home. Post-treatment assessments occur during weeks 11-14. |
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| Group B - Delayed Start | Active Comparator | Subjects undergo a 4-week baseline assessment (weeks 1-4), followed by a 6-week no-treatment reference period (weeks 5-10). Active treatment with the Walther System is then administered every second day for 6 weeks (weeks 11-16), starting with an initial supervised treatment at the clinic. Post-treatment assessments occur during weeks 17-20. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INMEST-treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Monthly Migraine Days | 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). | Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in monthly headache days | Between-group comparison of the difference in mean change in monthly headache days from baseline. | Weeks 7-10 |
| Mean change in migraine intensity | Between-group comparison of the difference in mean change in migraine intensity from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Device usability and user experience (combined questionnaires) | 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. | Throughout the 6-week treatment period |
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 50.
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:
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.
Anticipated compliance with prescribed treatment and follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl-Johan Pantzar, MSc, MSc | Contact | +46(0)739808065 | kj@abilion.com |
| Name | Affiliation | Role |
|---|---|---|
| Jan-Erik Juto, PhD, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INMEST-mottagningen Odenplan | Recruiting | Stockholm | 11327 | Sweden |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Weeks 7-10 |
| Mean change in duration of migraine attacks | Between-group comparison of the difference in mean change in migraine attack duration (hours) from baseline. | Weeks 7-10 |
| Proportion of attacks requiring rescue medication | Between-group comparison of the proportion of migraine attacks requiring rescue medication. | Weeks 7-10 |
| Number of participants with ≥30% and ≥50% reduction in monthly migraine days | Between-group comparison of the proportion of subjects achieving ≥30% and ≥50% reduction in monthly migraine days. | Weeks 7-10 |
| Mean change in PROMIS-PI SF-6b | 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. | Weeks 7-10 |
| Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ) | 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. | Weeks 7-10 |
| Mean change in Patient Global Impression of Severity (PGI-S) | 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. | Weeks 7-10 |
| Mean change in monthly migraine days | Change from baseline in monthly migraine days within each group. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in monthly headache days | Change from baseline in monthly headache days within each group. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in migraine intensity (6-point severity scale) | 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. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in duration of migraine attacks | Change from baseline in duration of migraine attacks (hours) within each group. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Proportion of migraine attacks requiring rescue medication | Proportion of migraine attacks requiring rescue medication within each group. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Number of participants with ≥30% and ≥50% reduction in monthly migraine days | Proportion of subjects achieving ≥30% and ≥50% reduction in monthly migraine days within each group. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in PROMIS-PI SF-6b | Change from baseline in PROMIS-PI SF-6b scores within each group. The raw scores are converted to standardized T-scores (mean = 50, SD = 10) based on the PROMIS calibration sample. Higher scores indicate greater pain-related interference. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ) | Change from baseline in PROMIS-PI SF-6b, MSQ, and PGI-S scores within each group. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in Patient Global Impression of Severity (PGI-S) | Change from baseline in PGI-S scores within each group. Measured on a 7-point scale (1 = least severe, 7 = most severe), where higher values indicate greater severity. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in monthly migraine days | Change from baseline in monthly migraine days, pooled across both groups. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in monthly headache days | Change from baseline in monthly headache days, pooled across both groups. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in migraine intensity (6-point severity scale) | Change from baseline in migraine intensity, pooled across both groups. Migraine intensity is assessed using a 6-point severity scale (1 = Very mild, 6 = Very severe), where higher scores indicate greater pain severity." | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in duration of migraine attacks | Change from baseline in duration of migraine attacks (hours), pooled across both groups. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Proportion of migraine attacks requiring rescue medication | Proportion of migraine attacks requiring rescue medication, pooled across both groups. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Number of participants with ≥30% and ≥50% reduction in monthly migraine days | Proportion of subjects achieving ≥30% and ≥50% reduction in monthly migraine days, pooled across both groups. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in PROMIS-PI SF-6b | Change from baseline in PROMIS-PI SF-6b scores, pooled across both groups. The raw scores are converted to standardized T-scores (mean = 50, SD = 10) based on the PROMIS calibration sample. Higher scores indicate greater pain-related interference. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ) | Change from baseline in PROMIS-PI SF-6b, MSQ, and PGI-S scores, pooled across both groups. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Mean change in Patient Global Impression of Severity (PGI-S) | Change from baseline in PGI-S scores, pooled across both groups. Measured on a 7-point scale (1 = least severe, 7 = most severe), where higher values indicate greater severity. | Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20 |
| Proportion of prescribed treatments completed | Compliance based on device usage logs or participant-reported treatment diaries. | Throughout the 6-week treatment period |
| Adverse Events / Serious Adverse Events / Device Effects | Number of treatment-related AEs, SAEs, ADEs, SADEs, and Unanticipated SADEs for the Walther System. | Through study completion (14 or 20 weeks, depending on treatment group) |
| Device Deficiencies | Number of device deficiencies for the Walther System. | Throughout the 6-week treatment period |
| Symptom trends (Symptom Questionnaire) | 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." | Throughout the 6-week treatment period |