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

INCLUSION

AND EXCLUSION CRITERIA:

Inclusion Criteria

1. The subject is legally competent, has been informed of the nature, the scope and therelevance of the study, voluntarily agrees to participation and the study'sprovisions, and has duly signed the informed consent form;

2. Male or female aged between 18 and 70 years (inclusive) at the time of providinginformed consent;

3. Diagnosed with chronic migraine with or without aura (≥15 headache days per monthincluding at least 8 migraine days for more than 3 months before screening)according to the International Headache Society classification (InternationalClassification 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 (ifany) (no change in type, frequency or dose) from screening to at least the 6-monthfollow-up;

7. Women of childbearing potential must be willing to use highly effectivecontraceptive methods (failure rate <1% per year when used consistently andcorrectly) 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 ongoingtreatment 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 otherwisecontraindicates participation in a clinical investigation;

10. Pregnant and lactating women;

11. Participation in a clinical investigation within 3 months of enrolment or plannedparticipation 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 thestudy, 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.