This trial will study whether bupivacaine delivered by the Tx360® device to the sphenopalatine ganglion can effectively treat chronic migraine headaches, compared to saline. The Tx360® is a nasal applicator which is FDA approved for transnasal medication delivery, including delivery to the SPG. The SPG has been implicated in a variety of cephalalgias, and accurate delivery of the medication to this area is critical for the success of the intervention.
1 Primary · 2 Secondary · Reporting Duration: Measured per month from end of 28-day screening/baseline phase to end of the 4-week treatment phase, and end of one month post- treatment, end ot two months post-treatment, and end of 3 months post-treatment.(EOS)
180 Total Participants · 2 Treatment Groups
Primary Treatment: Bupivacaine · Has Placebo Group · Phase 3
Age 18 - 65 · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you: