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

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-III beta criteria in the previous 12 months and/or MO during 28-day screening/baseline phase (Appendix B).
• •4. history of hemiplegic migraine, basilar migraine, cervicogenic headache, occipital neuralgia or post-traumatic headache as defined by ICHD-III beta criteria (Post traumatic headache needs to have developed within 7 days of the following: injury to the head, regaining of consciousness following injury to the head, or discontinuation of medications that impair ability to send or report headache following the injury to the head.
• •5. has failed greater than 2 migraine preventative medications due to lack of efficacy after adequate trial
• •6. received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring 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 judgment of the Investigator
• •10. unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure, in the judgment of the investigator
• •11. suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events, in the judgment of the investigator
• •12. any psychiatric condition with psychotic features, and/or any other psychiatric disorder not stable or well controlled, that would interfere in the ability to complete study activities
• •13. malignancy within the past year, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
• •14. nasal septal deformity such as cleft lip and palate, choanal atresia, atrophic rhinitis, 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) and nasal 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 the subject unsuitable for inclusion, or would interfere with the subject participating