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SPG Block with Tx360 for Chronic Migraine
Study Summary
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.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had problems with drugs or alcohol in the last 5 years.You have a neurological condition that is not stable or you have unusual signs during a neurological exam.You have a mental health condition with severe symptoms like hallucinations, or any other mental disorder that is not well controlled and might make it hard for you to take part in the study.You had cancer in the past year, except for certain types of skin cancer or early-stage cervical cancer that was successfully treated.You answer "yes" to question 9 of the PHQ-9 survey at any visit.You have had a specific type of nerve block using the Tx360® device in the past.You have taken too much opioid or butalbital medication in the past year or during the 28-day screening phase.You have certain types of migraines or headaches as defined by specific medical criteria.You have tried more than 2 migraine medications, but they didn't work for you.You are allergic to bupivacaine.You must be between 18 and 65 years old.You have frequent headaches that match the specific criteria for chronic migraine, as outlined in a medical guide.You have had injections of onabotulinumtoxinA in the head, face, or neck for migraine or other reasons in the past 4 months.You have certain nasal or facial conditions, recent injury or surgery, or abnormal nasal symptoms.You have to have at least 15 headache days in a month, with at least 8 of those days meeting specific criteria.You have a history of frequent migraine headaches, at least 15 days per month with 8 or more being migraine, for at least three months before screening.
- Group 1: Bupivacaine
- Group 2: saline
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are investigators looking for more individuals to take part in this clinical trial?
"That is correct. The clinicaltrial.gov website has information indicating that this study is looking for patients. The study was first posted on September 20th, 2017 and was updated on September 2nd, 2022. There are 7 locations for this trial and the goal is to have 180 patients total."
Who does this research project accept as participants?
"To be eligible for participation in this clinical trial, migraine sufferers between the ages of 18 and 65 are encouraged to apply. There is a total of 180 spots available."
Does Bupivacaine have the FDA's go-ahead for public use?
"Bupivacaine has been studied enough to support its safety in a Phase 3 trial, so it received a score of 3."
How many different sites are running this clinical trial?
"Presently, this clinical trial is operational at 7 different locations. If you are considering participating in this trial, know that there are centres near to Port Jefferson Station and Watertown in New york, as well as 7 other locations. By selecting the site nearest to you, you can reduce how much you need to travel."
What is the total number of people participating in this test?
"One hundred and eighty individuals that meet the specific conditions set forth by the researchers are needed in order to carry out this experiment. People who want to participate can do so at North Suffolk Neurology, PC in Port Jefferson Station, New york or Hudson Medical in New York, Massachusetts."
Does this research include people who are over the age of seventy?
"Following the age parameters set out in the study's inclusion criteria, the lower age limit for participants is 18 and the upper age limit is 65."
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What portion of applicants met pre-screening criteria?
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