Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Migraine device trial halted early – what we know

NCT ID NCT05843721

Symptom relief Sponsor: Chordate Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study followed 98 people with chronic migraine who used a device that delivers gentle oscillations inside the nose. The goal was to see if regular use could cut down on severe headache days. The trial was terminated early, so the full results are not available, but the approach aimed to provide a non-drug option for migraine relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intranasal kinetic oscillation stimulation device
What this could lead to
If effective, this device could offer a drug-free option to reduce migraine days for people with chronic migraine.
What could go wrong
The study was terminated early, so results are limited. It was also an uncontrolled trial, making it hard to know if benefits came from the device or chance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

98 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION AND EXCLUSION CRITERIA: Inclusion Criteria 1. 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; 2. Male or female aged between 18 and 70 years (inclusive) at the time of providing informed consent; 3. 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); 4. Migraine onset before the age of 65 years; 5. Reported history of migraine for at least 1 year before screening; 6. 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; 7. 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. Exclusion Criteria 1. Unable to distinguish between migraine headache and other headache types; 2. An ongoing upper respiratory infection, nasal tumors, or wounds in the nasal cavity. 3. Nasal cavity abnormalities that prevents catheter insertion. 4. A concomitant condition that could cause excessive nose bleeding or ongoing treatment with anticoagulant medication (except Aspirin and Clopidogrel). 5. A known allergy to polyurethane (polyurethane is used in the catheter balloon). 6. Systemic diseases with manifestations in the nose. 7. Previous treatment with radiation therapy to the nasal area. 8. Nasal surgery performed within the last six months. 9. 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; 10. Pregnant and lactating women; 11. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation; 12. Previous participation in this study; 13. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic migraine are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine

Contacts and locations

Locations

  • Centro Regionale Diagnosi e Cura delle Cefalee IRCCS National Neurological Institute "C. Mondino" Foundation

    Pavia, 27100, Italy

  • Department of Neurology, Institute of Neurological Sciences, Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Hull Royal Infirmary, Hull University Teaching Hospital NHS Trust

    Hull, HU3 2J, United Kingdom

  • IRCCS Istituto Auxologico Italiano U.O. Neurologia - Centro Cefalee

    Milan, 20149, Italy

  • IRCCS San Raffaele Pisana Dipartimento di Scienze Neurologiche Motorie e Sensoriali Unità per la Cura e la Ricerca su Cefalee e Dolore

    Roma, 00166, Italy

  • Kopfschmerzzentrum Frankfurt

    Frankfurt am Main, D-65929, Germany

  • Policlinico Universitario Campus Bio-Medico di Roma UOC Neurologia

    Roma, 00128, Italy

  • Shaare Zedek Medical Center, Neurology Clinics,

    Jerusalem, 9103102, Israel

  • St. George's University Hospitals NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden UniversitätsSchmerzCentrum

    Dresden, D-01307, Germany

  • Universitätsklinikum Essen (AöR) Klinik für Neurologie Kopfschmerz- und Schwindelambulanz

    Essen, D-45147, Germany

  • Universitätsklinikum Tübingen Klinik für Neurologie

    Tübingen, D-72076, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.