Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine

Launched by CHORDATE MEDICAL · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a treatment called intranasal kinetic oscillation for people suffering from chronic migraine. Chronic migraine is defined as having 15 or more headache days each month, with at least 8 of those being migraine days. The trial aims to gather information on how well this treatment works and its safety over an extended period.

To participate, individuals must be between 18 and 70 years old and have been diagnosed with chronic migraine for at least a year. They need to be able to continue their current migraine medications without any changes during the study. Participants can expect regular follow-ups and will be asked to keep a daily record of their headaches. It's important to note that some people will not be eligible, including those with certain nasal conditions or who have recently undergone nasal surgery. This study is currently recruiting participants, and everyone involved will receive detailed information to help them understand the process and their role in it.

Gender

ALL

Eligibility criteria

• 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.