Chronic MigraineNCT05843721
Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
A study testing KOS (Intranasal kinetic oscillation stimulation) in people with Chronic Migraine, run by Chordate Medical at 12 sites in 4 countries.
Trial summary
An non controlled, long term, multi center investigation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- KOS (Intranasal kinetic oscillation stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 8 Nov 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form;
- Male or female aged between 18 and 70 years (inclusive) at the time of providing informed consent;
- Diagnosed with chronic migraine with or without aura (≥15 headache days per month including at least 8 migraine days for more than 3 months before screening) according to the International Headache Society classification (International Classification of Headache Disorders III);
- Migraine onset before the age of 65 years;
- Reported history of migraine for at least 1 year before screening;
- Able and willing to maintain current prophylactic migraine medication regimen (if any) (no change in type, frequency or dose) from screening to at least the 6-month follow-up;
- Women of childbearing potential must be willing to use highly effective contraceptive methods (failure rate <1% per year when used consistently and correctly) during the study.
Who cannot join
- Unable to distinguish between migraine headache and other headache types;
- An ongoing upper respiratory infection, nasal tumors, or wounds in the nasal cavity.
- Nasal cavity abnormalities that prevents catheter insertion.
- A concomitant condition that could cause excessive nose bleeding or ongoing treatment with anticoagulant medication (except Aspirin and Clopidogrel).
- A known allergy to polyurethane (polyurethane is used in the catheter balloon).
- Systemic diseases with manifestations in the nose.
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- Previous treatment with radiation therapy to the nasal area.
- Nasal surgery performed within the last six months.
- Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation;
- Pregnant and lactating women;
- Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;
- Previous participation in this study;
- Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals.
- Only at baseline visit (day 0) If subject missed >4 days of eDiary entry, subject will be withdrawn.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany4 sites
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden UniversitätsSchmerzCentrum
Dresden, D-01307
Universitätsklinikum Essen (AöR) Klinik für Neurologie Kopfschmerz- und Schwindelambulanz
Essen, D-45147
Kopfschmerzzentrum Frankfurt
Frankfurt am Main, D-65929
Universitätsklinikum Tübingen Klinik für Neurologie
Tübingen, D-72076
Italy4 sites
IRCCS Istituto Auxologico Italiano U.O. Neurologia - Centro Cefalee
Milan, 20149
Centro Regionale Diagnosi e Cura delle Cefalee IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, 27100
Policlinico Universitario Campus Bio-Medico di Roma UOC Neurologia
Roma, 00128
IRCCS San Raffaele Pisana Dipartimento di Scienze Neurologiche Motorie e Sensoriali Unità per la Cura e la Ricerca su Cefalee e Dolore
Roma, 00166
United Kingdom3 sites
Department of Neurology, Institute of Neurological Sciences, Queen Elizabeth University Hospital
Glasgow, G51 4TF
Hull Royal Infirmary, Hull University Teaching Hospital NHS Trust
Hull, HU3 2J
St. George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Israel1 site
Shaare Zedek Medical Center, Neurology Clinics,
Jerusalem, 9103102
About this study
Official title: An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
An non controlled, long term, multi center investigation
Read the detailed description
Subjects who provided written informed consent and are eligible for the study will be asked to complete a daily diary for 4 weeks during the screening period. In the diary the subjects will record headache and migraine days, any changes in their health, and concomitant medications they may be using. The data collected in the diary during this screening period will be used as Baseline for the performance assessments.
A non-controlled, long term, multi-center investigation for symptom improvement in subjects suffering headache and migraine attacks.
During the run-in (baseline) period and through the whole study the subjects will continue using their existing prescribed or over the counter (OTC) treatments.
Following the run-in period (4 weeks) the subjects will be treated six times within a period that is approximately 6 weeks. The first treatment will be given the first day after the run-in period.
During 12-month follow-up period (from the time of the first treatment), subjects will be treated when needed but a maximum of 14 treatments.
- Conditions
- Chronic Migraine
- Being tested
- KOS (Intranasal kinetic oscillation stimulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOS (Intranasal kinetic oscillation stimulation)Device
Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment.
| Study group | Role | What they receive |
|---|---|---|
| KOS treatment | Other | Treatment with intranasal kinetic oscillation stimulation (KOS) Receives: Device: KOS (Intranasal kinetic oscillation stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of intranasal kinetic oscillation stimulation using the Chordate System S220 on monthly headache days with moderate to severe intensity after approx 6 weeks of treatment.
Change in proportion of days with headache with moderate to severe intensity compared to the four week period starting the day after the third treatment Headache days are collected in electronic diary (eDiary)
Measured: Baseline to 6 weeks
Secondary outcomes (6)
To evaluate the efficacy of treatment with KOS on monthly migraine days (regardless of intensity) Description: Migraine days are collected in an eDiary.
Migraine days is collected in an eDiary.
Measured: Baseline to 12 month
To evaluate the incidence and severity of adverse events (AEs) and adverse device effects (ADEs) following treatment with the Chordate System S220.
All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with KOS
Measured: Baseline to 12 month
Number of patients who are responders
Responders are classified as responder (less migraine/headache days) or non-responder (same or worsening of migraine/headache days).
A responder is a patient who has decrease of headache/migraine days whilst a non responder had no or the same number of headache/migraine days
Measured: Baseline to 12 month
Number of patients who decrease use of abortive medication
Intake of abortive medications are registered in eDiary and will be calculated on patient level
Measured: Baseline to 12 month
Mean change in Headache Impact Test (HIT-6)
HIT-6 consist of 6 questions HIT-6 with scores from 6 to 13 where 13 is worst case per question so lower score is better outcome than high scores.
Measured: Baseline to 12 month
Mean change in Subject global severity
Patient Global severity is a scale with four (4) scores, where normal (0) is the lowest and show no problems whilst severe (3) is the worst score 0. Normal
- Mild
- Moderate
- Severe
Measured: Baseline to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 Nov 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Why it stopped: Difficulties recruiting patients in combination with good results in data analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chordate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J Goadsby, Prof,MD,PhD, Principal investigator, Wellcome Foundation Building, Denmark Hill Campus King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843721
- Sponsor's protocol ID
- PM010
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to uncertainties in EU data protection legislation individual de-identified participant data are not shared. The main uncertainty is the concept of what "de-identified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as de-identified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in punishment by EU data protection authorities. The sponsor wants to avoid this.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Post-marketing Clinical Follow-up Investigation to Follow Long-term Performance and Safety of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine
- ClinicalTrials.gov ID
- NCT05843721
- Acronym / sponsor ID
- PM010
- Conditions
- Chronic Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties recruiting patients in combination with good results in data analysis.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Chordate MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 6 May 2023 (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.
An non controlled, long term, multi center investigation
Detailed description
Subjects who provided written informed consent and are eligible for the study will be asked to complete a daily diary for 4 weeks during the screening period. In the diary the subjects will record headache and migraine days, any changes in their health, and concomitant medications they may be using. The data collected in the diary during this screening period will be used as Baseline for the performance assessments.
A non-controlled, long term, multi-center investigation for symptom improvement in subjects suffering headache and migraine attacks.
During the run-in (baseline) period and through the whole study the subjects will continue using their existing prescribed or over the counter (OTC) treatments.
Following the run-in period (4 weeks) the subjects will be treated six times within a period that is approximately 6 weeks. The first treatment will be given the first day after the run-in period.
During 12-month follow-up period (from the time of the first treatment), subjects will be treated when needed but a maximum of 14 treatments.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KOS treatment | Other | Device: KOS (Intranasal kinetic oscillation stimulation)Treatment with intranasal kinetic oscillation stimulation (KOS) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form;
- Male or female aged between 18 and 70 years (inclusive) at the time of providing informed consent;
- Diagnosed with chronic migraine with or without aura (≥15 headache days per month including at least 8 migraine days for more than 3 months before screening) according to the International Headache Society classification (International Classification of Headache Disorders III);
- Migraine onset before the age of 65 years;
- Reported history of migraine for at least 1 year before screening;
Key exclusion criteria (14 listed)
- Unable to distinguish between migraine headache and other headache types;
- An ongoing upper respiratory infection, nasal tumors, or wounds in the nasal cavity.
- Nasal cavity abnormalities that prevents catheter insertion.
- A concomitant condition that could cause excessive nose bleeding or ongoing treatment with anticoagulant medication (except Aspirin and Clopidogrel).
- A known allergy to polyurethane (polyurethane is used in the catheter balloon).
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 |
|---|---|---|
| KOS (Intranasal kinetic oscillation stimulation)Treatment is 10 minutes in each nasal cavity. Totally 2 x 10 minutes per treatment. | Device | KOS treatment |
Primary outcome
To evaluate the efficacy of intranasal kinetic oscillation stimulation using the Chordate System S220 on monthly headache days with moderate to severe intensity after approx 6 weeks of treatment.
Time frame: Baseline to 6 weeks
Change in proportion of days with headache with moderate to severe intensity compared to the four week period starting the day after the third treatment Headache days are collected in electronic diary (eDiary)
6 secondary outcomes
To evaluate the efficacy of treatment with KOS on monthly migraine days (regardless of intensity) Description: Migraine days are collected in an eDiary.
Time frame: Baseline to 12 month
To evaluate the incidence and severity of adverse events (AEs) and adverse device effects (ADEs) following treatment with the Chordate System S220.
Time frame: Baseline to 12 month
Number of patients who are responders
Time frame: Baseline to 12 month
Number of patients who decrease use of abortive medication
Time frame: Baseline to 12 month
Mean change in Headache Impact Test (HIT-6)
Time frame: Baseline to 12 month
Mean change in Subject global severity
Time frame: Baseline to 12 month
Results and safety
The study was stopped early (reason given: Difficulties recruiting patients in combination with good results in data analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No. Due to uncertainties in EU data protection legislation individual de-identified participant data are not shared. The main uncertainty is the concept of what "de-identified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as de-identified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in punishment by EU data protection authorities. The sponsor wants to avoid this.
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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.
Peter J Goadsby, Prof,MD,PhD principal investigator
Wellcome Foundation Building, Denmark Hill Campus King's College London
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOS (Intranasal kinetic oscillation stimulation) in people with Chronic Migraine, run by Chordate Medical at 12 sites in 4 countries.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Italy, United Kingdom, Israel. 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?
The study was stopped early (reason given: Difficulties recruiting patients in combination with good results in data analysis.). Results are not available in the source record.
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?
To evaluate the efficacy of intranasal kinetic oscillation stimulation using the Chordate System S220 on monthly headache days with moderate to severe intensity after approx 6 weeks of treatment. (time frame: Baseline to 6 weeks). 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 12 Sep 2025.