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

Prior treatment

• 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).
• has failed greater than 2 migraine preventative medications due to lack of efficacy after adequate trial
• 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.
• has previously received SPG blocks using the Tx360®device
• recent nasal/sinus surgery (\< 3 months)
• received any investigational agents within 30 days prior to Visit 1

Other illness

• 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.
• history of substance abuse and/or dependence within the past 5 years, in the judgment of the Investigator
• unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure, in the judgment of the investigator
• 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
• 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
• 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
• nasal septal deformity such as cleft lip and palate, choanal atresia, atrophic rhinitis, rhinitis, or septal perforation
• bleeding disorder such as Von Willebrand disease or hemophilia
• skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding
• allergy to bupivacaine
• 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

Other

• Subjects will be excluded that meet the following criteria:
• unable to complete headache records (diary) as required by protocol
• pregnant, actively trying to become pregnant, or breast-feeding
• has a planned military deployment within the 6 months post screening
• recent nasal/midface trauma (\< 3 months)
• nasal or facial fracture
• severe respiratory distress
• neoplasm such as Angiofibroma, sinus tumor, granuloma
• nasal congestion present more than 10 days with fever (temperature ≥ 100.4 F) and nasal mucous is an abnormal color
• recurrent nose bleeds
• has a score \> 0 on question 9 of PHQ-9 at any visit
• plans to participate in another clinical study at any time during this study

• Subjects may be included that meet the following criteria:
  • willing to participate and sign informed consent
  • ability to understand informed consent and study procedures, including able to use the electronic Daily Headache Diary
  • in general good health based on investigator's judgment
  • male or female, age must be between 18 to 65 years of age, inclusive
  • chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013), as follows:
  • History of frequent headaches suggestive of chronic migraine (at least 15 days per month with 8 or more being migraine) for at least three months prior to screening
  • Verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase demonstrating headaches at least 15 days, with at least 8 days per month fulfilling any one of the following
  • Qualify as being a migraine
  • Relieved by migraine specific acute medications
  • onset of migraine before age 50
  • able to differentiate migraine from any other headache they may experience (e.g., tension-type headache)
  • stable history of migraine at least 3 months prior to screening with headache free periods
  • not currently taking a migraine preventive OR has been taking a stable dose of a preventive for at least 60 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period
  • subjects on migraine preventative should have stable headache pattern
  • subject is either not of childbearing potential, as defined in the methods section, or if they are of childbearing potential they agree either to remain abstinent or use (or have their partner use) an acceptable method of birth control for the duration of the study
  • demonstrated compliance with the electronic Daily Headache Diary during the 28-day screening/baseline phase as defined by entry of headache data on a minimum of 22 to 28 days (80% diary compliance) in or completing the study.