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Chronic MigraineNCT05273151

A Study With Intranasal Kinetic Oscillation Stimulation (KOS) in the Prevention of Chronic Migraine

A study testing KOS (Intranasal kinetic oscillation stimulation) in people with Chronic Migraine, run by Chordate Medical at 2 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

An open pilot study, non-controlled, single 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
13 participants
Where
2 sitesUnited Kingdom
Study dates
4 Dec 2023to 30 Jun 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 as suffering from 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 50 years.
  • Reported history of migraine for at least 1 year before screening.
  • If subjects are on a preventive treatment at the time of screening, this must have been stable over the preceding 3 months.
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  • If subjects are on preventive treatment at the time of screening, they have to be able and willing to maintain current preventive treatment regimen (no change in type, frequency or dose) from screening to end of follow-
  • Failed at least 3 different preventive medications and 3 months of treatment with a CGRP targeting therapy.
  • 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 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;

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Hull Royal Infirmary, Hull University Teaching Hospital

    Hull, HU3 2JZ,

  • Wolfson Centre for Age-Related Diseases Institute of Psychiatry, Psychology and Neuroscience Wellcome Foundation Building, Denmark Hill Campus King's College

    London, SE5 9PJ,

Other trials in United Kingdom

About this study

Official title: An Open Pilot Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine on Patients Not Responding to a Preventive Treatment Targeting the CGRP Pathway

An open pilot study, non-controlled, single center investigation.

Read the detailed description

An open pilot study, non-controlled, single center investigation. The study consists of a 4-week screening period, a 6-week treatment period, and a 12 week follow-up period.

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.

Subjects who completed the screening period and continue to meet the eligibility criteria after review of diary entries by the investigator will receive treatment. The subjects will receive 6 treatments with the Chordate System S220 at weekly intervals at the site (Day 0 to 35; treatment Visit [V] 1 to 6) and continue to maintain a daily diary.

After completion of the 6-week study treatment period (V1 to V6), subjects will be treated monthly and followed up for another 12 weeks. The final visit will be performed on Day 125, 12 weeks after the last study treatment. During the 12-week follow-up, the subjects will continue to complete a daily diary.

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 groups in NCT05273151
Study groupRoleWhat they receive
KOS treatmentOtherTreatment 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.

  1. Mean change in headache days

    Change in headache days with moderate to severe intensity after 6 weeks of treatment. Headache days are collected in eDiary

    Measured: baseline to 6 weeks

Secondary outcomes (8)

  1. Mean change in Migraine days Mean change of migraine days, responder rate, use of abortive medication, health-related quality of life and disability, and patient's global impression of severity 12 weeks (90 days)

    Migraine days is collected in an eDiary.

    Measured: Baseline to 12 weeks

  2. Incidence of adverse events (AEs) and adverse device effects (ADEs)

    All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following treatment with the Chordate System 220

    Measured: Baseline to 12 weeks

  3. 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 respondes is a patient who has decrease of headaches/migraine days whilst a non responder had no or the same number of headache/migraine days

    Measured: baseline to 12 weeks

  4. Number of patients who decrease use of abortive medication

    Intake of abortive medications are registred in eDiary and will be calculated on patient level

    Measured: baseline to 12 weeks

  5. Mean change in Hospital Anxiety and Depression Scale (HADS)

    HADS is a scale with 7 questions related to anxiety and 7 questions related to depression Anxiety can have 0-21 points (lower score means no anxiety) and Depression 0-21 points (higher score means no depression)

    Measured: baseline to 12 weeks

  6. 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 means less problems

    Measured: baseline to 12 weeks

  7. 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

    1. Mild
    2. Moderate
    3. Severe

    Measured: baseline to 12 weeks

  8. Mean change in headache days

    Change in headache days with moderate to severe intensity from eDiary

    Measured: week 6-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start4 Dec 2023
  3. Primary completion3 Jun 2025
  4. Study completion30 Jun 2025

Why it stopped: Slow inclusion due to new treatment (Gepants)

Resources

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
Model description
Open label Investigation
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273151
Sponsor's protocol ID
PM009
Status last verified
Jul 2025
First submitted
31 Jan 2022
Last updated
31 Jul 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 deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" 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 deidentified 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.

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 2 sites in United Kingdom.

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 9 inclusion and 13 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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: Slow inclusion due to new treatment (Gepants)). 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?

Mean change in headache days (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?

On the ClinicalTrials.gov record for NCT05273151.

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 31 Jul 2025.

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