MigraineA-MI-01NCT07279623
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
A study testing INMEST-treatment in people with Migraine, run by Abilion Medical Systems AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- INMEST-treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 21 Oct 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
- Anticipated compliance with prescribed treatment and follow-up.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Migraine
- Being tested
- INMEST-treatment
- Keywords
- Migraine, Migraine prophylaxis / Preventive treatment, Neuromodulation, Intra-nasal mechanical stimulation, INMEST, Medical device, Chronic migraine, Episodic migraine, Headache disorders
- Medical subject headings
- Migraine Disorders, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INMEST-treatmentDevice
Also called Walther System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: INMEST-treatment |
| 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. Receives: Device: INMEST-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period)
Secondary outcomes (29)
Mean change in monthly headache days
Between-group comparison of the difference in mean change in monthly headache days from baseline.
Measured: Weeks 7-10
Mean change in migraine intensity
Between-group comparison of the difference in mean change in migraine intensity from baseline.
Measured: 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.
Measured: Weeks 7-10
Proportion of attacks requiring rescue medication
Between-group comparison of the proportion of migraine attacks requiring rescue medication.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 7-10
Mean change in monthly migraine days
Change from baseline in monthly migraine days within each group.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion (14 or 20 weeks, depending on treatment group)
Device Deficiencies
Number of device deficiencies for the Walther System.
Measured: Throughout the 6-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start21 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abilion Medical Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia, Insamlingsstiftelsen för främjande av forskning avseende INMEST
- Responsible party
- Sponsor
- Investigators
- Jan-Erik Juto, PhD, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279623
- Sponsor's protocol ID
- A-MI-01
- Other IDs
- CIV-25-05-052936
- Acronym
- A-MI-01
- Status last verified
- Nov 2026
- First submitted
- 18 Nov 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07279623
- Acronym / sponsor ID
- A-MI-01 / A-MI-01
- Conditions
- Migraine
- Keywords
- Migraine, Migraine prophylaxis / Preventive treatment, Neuromodulation, Intra-nasal mechanical stimulation, INMEST, Medical device, Chronic migraine, Episodic migraine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Abilion Medical Systems ABIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia, Insamlingsstiftelsen för främjande av forskning avseende INMEST
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Early Start | Active comparator | Device: INMEST-treatmentSubjects 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. |
| Group B - Delayed Start | Active comparator | Device: INMEST-treatmentSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INMEST-treatmentAlso: Walther SystemHand-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. | Device | Group A - Early Start, Group B - Delayed Start |
Primary outcome
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).
29 secondary outcomes
Mean change in monthly headache days
Time frame: Weeks 7-10
Mean change in migraine intensity
Time frame: Weeks 7-10
Mean change in duration of migraine attacks
Time frame: Weeks 7-10
Proportion of attacks requiring rescue medication
Time frame: Weeks 7-10
Number of participants with ≥30% and ≥50% reduction in monthly migraine days
Time frame: Weeks 7-10
Mean change in PROMIS-PI SF-6b
Time frame: Weeks 7-10
Mean change in Migraine-Specific Quality of Life Questionnaire (MSQ)
Time frame: Weeks 7-10
Mean change in Patient Global Impression of Severity (PGI-S)
Time frame: Weeks 7-10
Mean change in monthly migraine days
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Mean change in monthly headache days
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)
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Mean change in duration of migraine attacks
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Proportion of migraine attacks requiring rescue medication
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
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Mean change in PROMIS-PI SF-6b
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)
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)
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Mean change in monthly migraine days
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Mean change in monthly headache days
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)
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Mean change in duration of migraine attacks
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Proportion of migraine attacks requiring rescue medication
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
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Mean change in PROMIS-PI SF-6b
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)
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)
Time frame: Group A: Weeks 1-4 → 11-14; Group B: Weeks 7-10 → 17-20
Proportion of prescribed treatments completed
Time frame: Throughout the 6-week treatment period
Adverse Events / Serious Adverse Events / Device Effects
Time frame: Through study completion (14 or 20 weeks, depending on treatment group)
Device Deficiencies
Time frame: Throughout the 6-week treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Erik Juto, PhD, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INMEST-treatment in people with Migraine, run by Abilion Medical Systems AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Monthly Migraine Days (time frame: Weeks 7-10 (Group A: Treatment performance period; Group B: No treatment reference period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.