Condition: Headache, Migraine · Sponsor: Tian Medical Inc.
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Yale University | New Haven, Connecticut, United States | — |
| New England Institute for Clinical Research | Stamford, Connecticut, United States | — |
| Eisenhower Army Medical Center | Fort Gordon, Georgia, United States | — |
| Crescent City Headache and Neurology Centre | Chalmette, Louisiana, United States | — |
| MedVadis Research | Watertown, Massachusetts, United States | — |
| Clinvest Research, LLC | Springfield, Missouri, United States | — |
| Hudson Medical | New York, New York, United States | — |
| North Suffolk Neurology, PC | Port Jefferson Station, New York, United States | — |
| Womack Army Medical Senter | Fort Bragg, North Carolina, United States | — |
| Preferred Primary Care Physicians | Pittsburgh, Pennsylvania, United States | — |
| Lone Star Neurology | Frisco, Texas, United States | — |
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Source record: clinicaltrials.gov/study/NCT03337620