Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine

Inclusion Criteria:

• Subjects may be included that meet the following criteria:

1. willing to participate and sign informed consent
2. ability to understand informed consent and study procedures, including able touse the electronic Daily Headache Diary
3. in general good health based on investigator's judgment
4. male or female, age must be between 18 to 65 years of age, inclusive
5. chronic migraine meeting the diagnostic criteria listed in the InternationalClassification of Headache Disorders (ICHD-III beta version, 2013), as follows:
6. History of frequent headaches suggestive of chronic migraine (at least 15days per month with 8 or more being migraine) for at least three monthsprior to screening
7. Verification of headache frequency through prospectively collected baselineinformation during the 28-day screening/baseline phase demonstratingheadaches at least 15 days, with at least 8 days per month fulfilling anyone of the following
8. Qualify as being a migraine
9. Relieved by migraine specific acute medications
10. onset of migraine before age 50
11. able to differentiate migraine from any other headache they may experience (e.g.,tension-type headache)
12. stable history of migraine at least 3 months prior to screening with headachefree periods
13. not currently taking a migraine preventive OR has been taking a stable dose of apreventive for at least 60 days prior to screening and agrees to not start, stop,or change medication and/or dosage during the study period a) subjects on migraine preventative should have stable headache pattern
14. subject is either not of childbearing potential, as defined in the methodssection, or if they are of childbearing potential they agree either to remainabstinent or use (or have their partner use) an acceptable method of birthcontrol for the duration of the study
15. demonstrated compliance with the electronic Daily Headache Diary during the 28-day screening/baseline phase as defined by entry of headache data on a minimumof 22 to 28 days (80% diary compliance) in or completing the study.

Exclusion Criteria: Subjects will be excluded that meet the following criteria:

1. unable to complete headache records (diary) as required by protocol
2. pregnant, actively trying to become pregnant, or breast-feeding
3. history of medication overuse (MO) of opioids, or butalbital, as defined by ICHD-IIIbeta criteria in the previous 12 months and/or MO during 28-day screening/baselinephase (Appendix B).
4. history of hemiplegic migraine, basilar migraine, cervicogenic headache, occipitalneuralgia or post-traumatic headache as defined by ICHD-III beta criteria (Posttraumatic headache needs to have developed within 7 days of the following: injury tothe head, regaining of consciousness following injury to the head, or discontinuationof medications that impair ability to send or report headache following the injury tothe head.
5. has failed greater than 2 migraine preventative medications due to lack of efficacyafter adequate trial
6. received onabotulinumtoxinA for migraine or for any medical or cosmetic reasonsrequiring injections in the head, face, or neck during the 4 months before screening.
7. has a planned military deployment within the 6 months post screening
8. has previously received SPG blocks using the Tx360®device
9. history of substance abuse and/or dependence within the past 5 years, in the judgmentof the Investigator
10. unstable neurological condition or a significantly abnormal neurological examinationwith focal signs or signs of increased intracranial pressure, in the judgment of theinvestigator
11. suffers from a serious illness, or an unstable medical condition, one that couldrequire hospitalization, or could increase the risk of adverse events, in the judgmentof the investigator
12. any psychiatric condition with psychotic features, and/or any other psychiatricdisorder not stable or well controlled, that would interfere in the ability tocomplete study activities
13. malignancy within the past year, except for basal or squamous cell carcinoma of theskin or carcinoma in situ of the cervix that has been successfully treated
14. nasal septal deformity such as cleft lip and palate, choanal atresia, atrophicrhinitis, rhinitis, or septal perforation
15. recent nasal/midface trauma (< 3 months)
16. nasal or facial fracture
17. recent nasal/sinus surgery (< 3 months)
18. bleeding disorder such as Von Willebrand disease or hemophilia
19. severe respiratory distress
20. neoplasm such as Angiofibroma, sinus tumor, granuloma
21. nasal congestion present more than 10 days with fever (temperature ≥ 100.4 F) andnasal mucous is an abnormal color
22. skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding
23. recurrent nose bleeds
24. allergy to bupivacaine
25. has a score > 0 on question 9 of PHQ-9 at any visit
26. received any investigational agents within 30 days prior to Visit 1
27. plans to participate in another clinical study at any time during this study
28. have any other conditions that in the judgment of the Investigator would make thesubject unsuitable for inclusion, or would interfere with the subject participating