Intranasal stimulation to prevent chronic migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open pilot study investigates the effectiveness of intranasal kinetic oscillation stimulation (KOS) in preventing chronic migraines. Participants will undergo a 4-week screening period followed by a 6-week treatment phase where they will receive six weekly KOS treatments. Throughout the study, subjects will maintain a daily diary to record headache and migraine occurrences, which will help assess the treatment's impact. After the treatment phase, participants will be monitored for an additional 12 weeks to evaluate long-term effects.

Why it matters

Who can join: the full rules

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 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);
4. Migraine onset before the age of 50 years.
5. Reported history of migraine for at least 1 year before screening.
6. If subjects are on a preventive treatment at the time of screening, this must have been stable over the preceding 3 months.
7. 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-
8. Failed at least 3 different preventive medications and 3 months of treatment with a CGRP targeting therapy.
9. 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 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;

Where it's running

• Hull Royal Infirmary, Hull University Teaching Hospital
  Hull, United Kingdom Recruiting
• Wolfson Centre for Age-Related Diseases Institute of Psychiatry, Psychology and Neuroscience Wellcome Foundation Building, Denmark Hill Campus King's College
  London, United Kingdom Recruiting
• Kopfschmerzzentrum Frankfurt
  Frankfurt, Germany Not yet recruiting
• Universitätsklinik für Neurologie Inselspital
  Bern, Switzerland Withdrawn

Study contacts

• Principal investigator: Peter J Goadsby, Prof,MD, PhD — Wellcome Foundation Building, Denmark Hill Campus King's College London
• Study coordinator: Peter J Goadsby, Prof,MD, PhD
• Email: peter.goadsby@kcl.ac.uk
• Phone: +44-20-3299 3106

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.