Intranasal stimulation to prevent chronic migraines

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

This study is testing if a new nasal treatment can help people with chronic migraines have fewer headaches and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chordate Medical (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 4 sites (Frankfurt and 3 other locations)
• Trial ID: NCT05273151 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of chronic migraine experiencing at least 15 headache days per month.

Not a fit: Patients with migraines that do not meet the chronic criteria or those with migraine onset after age 50 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of chronic migraines for patients.

How similar studies have performed: While this approach is novel, similar studies exploring non-invasive stimulation techniques for migraine prevention have shown promising results.

Eligibility 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 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 this trial is running

Frankfurt and 3 other locations

• Kopfschmerzzentrum Frankfurt — Frankfurt, Germany (Not_yet_recruiting)
• Universitätsklinik für Neurologie Inselspital — Bern, Switzerland (Withdrawn)
• 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)

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

Conditions Chronic Migraine