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

NCT03337620 | Completed Phase 3 DMC FDA Device

• 1 other identifier: 16-001TI
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Headache, Migraine

Keywords

chronic

Outcome Measures

Primary Outcomes (1)

• Change in Number of Migraine Headaches During Treatment Phase

  Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days during treatment.

  From 28-day screening/baseline phase to the end of the 4-week treatment phase.

Secondary Outcomes (2)

• Change in Number of Migraine Headache Days Post-Treatment

  From 28-day screening/baseline to end of one month post-treatment, end of two months post-treatment, and end of three months post treatments (EOS)

• Safety/Tolerability of TX360 Device Based on Adverse Effects

  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)

Other Outcomes (6)

• Efficacy Evaluation Based on Change in Mean Headache Severity

  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)

• Efficacy Evaluation Based on Change in Mean Number of Headache Days per Month

  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)

• Comparison of Response Rate

  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)

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Bupivacaine is a local anesthestic that will be delivered to the SPG by the Tx360 device.

Device: Tx360

saline

PLACEBO COMPARATOR

Saline is being used as a placebo treatment that will be delivered to the SPG by the Tx360 device.

Device: Tx360

Interventions

Tx360 DEVICE

Tx360 used to deliver active and placebo drug interventions to SPG.

Bupivacaine; saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Tian Medical Inc.: lead
• TAMM Net, Inc.: collaborator
• Clinvest Research, LLC: collaborator
• Ki Health Partners. LLC: collaborator

Study Sites (11)

Yale University

New Haven, Connecticut, 06519, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905, United States

Location

Crescent City Headache and Neurology Centre

Chalmette, Louisiana, 70043, United States

Location

MedVadis Research

Watertown, Massachusetts, 02472, United States

Location

Clinvest Research, LLC

Springfield, Missouri, 65810, United States

Location

Hudson Medical

New York, New York, 10007, United States

Location

North Suffolk Neurology, PC

Port Jefferson Station, New York, 11776, United States

Location

Womack Army Medical Senter

Fort Bragg, North Carolina, 28310, United States

Location

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, 15236, United States

Location

Lone Star Neurology

Frisco, Texas, 75035, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Tian Xia, MD

  Tian Medical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subject, investigator, study coordinator, and additional study staff will remain blinded. One member of the staff will assign subjects to a treatment group based on a computerized randomization number produced by a computer software system. The number will correspond to a kit number, of which the staff member will then use to prepare the Tx360® device for each of the subject's treatments during the 4-week treatment phase. If the clinical site has a pharmacy, it is preferred that the pharmacy receive the study medication and Tx360® devices, maintain custody of the study medication and Tx360® devices during the study, and prepared the medication in Tx360® devices for each subject's treatment, according to the computer-generated randomization. In order to maintain subject-blinding during the active phase of the study, subjects will be given a piece of lemon candy prior to each procedure as a taste distractor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multi-center, double blind, parallel, prospective, randomized; 28 days of screening; 4 weeks active treatment; 3 months of follow-up post-treatment

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 9, 2017
• Study Start: September 20, 2017
• Primary Completion: November 15, 2023
• Study Completion: December 29, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)