Ki Health Partners LLC

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs(monthly migraine days)/month) requiring preventive treatment.
Enrolled patients will receive DAXXIFY (DAX/Doxibutlinumtoxin A)administered subcutaneously per the EEG paradigm (injection pattern).
The safety and efficacy outcome measures will be assessed at selected dosing segments during the 24-week treatment phase as well as the Post Treatment (4 weeks).
There are 2 sites in the U.S. participating, where a total of 20 patients will be enrolled.

This is a prospective, multi-center, unblinded study in patients with migraine (≥ 8 MMDs/month) requiring preventive treatment. Enrolled patients will receive DAX administered subcutaneously using an established, published, legacy injection paradigm (referred to herein as the "standard paradigm"). The safety and efficacy outcome measures will be assessed at selected dosing segments during the 24-week treatment phase.

This is a double blind placebo-controlled study which will evaluate the efficacy of bupivacaine compared to saline, delivered by the Tx360® device to the sphenopalatine ganglion (SPG), to treat chronic migraine headache. The Tx360® is a nasal applicator which is cleared through the FDA for transnasal medication delivery, including delivery to the SPG. The SPG has been implicated in a variety of cephalalgias. It is critical to the success of this intervention that the blocking agent be accurately delivered to this area as it is the only non-bony access to the pterygopalatine fossa (PPF). Subjects meeting inclusion/exclusion criteria will receive 12 intranasal treatments to the SPG over a period of 4 weeks with follow-up monthly for an additional 3 months post-treatment.