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

Completed · Phase 3 · Has a placebo group

Conditions studied: Headache, Migraine

In brief

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.

Key facts

Study ID

NCT03337620

Run by

Tian Medical Inc.

People needed

174

Starts

2017-09-20

Expected to finish

2023-12-29

Last updated by the study team

2024-01-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• a) 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.

You may not qualify if…

• 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
• 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).
• 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.
• 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 a planned military deployment within the 6 months post screening
• has previously received SPG blocks using the Tx360®device
• 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
• recent nasal/midface trauma (< 3 months)
• nasal or facial fracture
• recent nasal/sinus surgery (< 3 months)
• bleeding disorder such as Von Willebrand disease or hemophilia
• 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
• skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding
• recurrent nose bleeds
• allergy to bupivacaine

Where it is running

• 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

Full record on ClinicalTrials.gov

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