An interventional study of INMEST-treatment in Migraine, sponsored by Abilion Medical Systems AB. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Abilion Medical Systems AB · Not applicable, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 110 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Abilion Medical Systems AB is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If subject is on a prophylactic migraine medication regimen:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: INMEST-treatment
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.
Device: INMEST-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.
Also known as: Walther System
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).
Time frame: Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period)
Mean change in monthly headache days
Between-group comparison of the difference in mean change in monthly headache days from baseline.
Time frame: Weeks 7-10
Mean change in migraine intensity
Between-group comparison of the difference in mean change in migraine intensity from baseline.
Time frame: 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.
Time frame: Weeks 7-10
Proportion of attacks requiring rescue medication
Between-group comparison of the proportion of migraine attacks requiring rescue medication.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 7-10
Mean change in monthly migraine days
Change from baseline in monthly migraine days within each group.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion (14 or 20 weeks, depending on treatment group)
Device Deficiencies
Number of device deficiencies for the Walther System.
Time frame: Throughout the 6-week treatment period
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.
Time frame: 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."
Time frame: Throughout the 6-week treatment period
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Nov 2026, 13 months after the start.
Of 49 industry-sponsored interventional studies with no phase under Migraine Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 22. This study's planned 13 months is above that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 28, 2026: primary completion Sep 2026 → Nov 2026 and completion Sep 2026 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Abilion Medical Systems AB