SPG Block with Tx360 for Chronic Migraine

Recruiting at 10 trial locations

Overseen By Carla Griffin

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tian Medical Inc.

Must not be taking: Opioids, Butalbital

Disqualifiers: Pregnancy, Substance abuse, Unstable condition, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

174 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a nasal spray that delivers a numbing medication to reduce pain in people with frequent migraines. It targets a specific nerve area inside the nose to block pain signals, aiming to help those who suffer from chronic migraines.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on a migraine preventive, you must have been on a stable dose for at least 60 days before the trial and agree not to change it during the study.

What data supports the effectiveness of the treatment Tx360 for chronic migraine?

Research shows that using the Tx360 device to deliver a sphenopalatine ganglion (SPG) block with bupivacaine can effectively reduce pain in people with chronic migraines. This method has been found to decrease headache intensity over time and is well-tolerated by patients. ^{1 2 3 4 5}

How does the treatment Tx360 for chronic migraine differ from other treatments?

The Tx360 treatment for chronic migraine is unique because it involves a sphenopalatine ganglion (SPG) block, which is a procedure that targets a specific nerve cluster in the face to relieve pain. This approach is different from other migraine treatments that often involve oral medications or injections targeting different pathways, such as CGRP inhibitors or botulinum toxin. ^{6 7 8 9 10}

Research Team

Tian Xia, MD

Principal Investigator

Tian Medical

Eligibility Criteria

This trial is for adults aged 18-65 with chronic migraines, as defined by having headaches at least 15 days per month. Participants must be in good health, not pregnant or breastfeeding, and willing to use birth control if applicable. They should have a stable dose of migraine prevention medication if currently taking any and must comply with using an electronic headache diary.

Inclusion Criteria

Subjects must be willing to participate and sign informed consent

Subjects must be in general good health based on the investigator's judgment

Subjects must have the ability to understand informed consent and study procedures, including the ability to use the electronic Daily Headache Diary

Exclusion Criteria

Subjects unable to complete headache records (diary) as required by protocol

You have had problems with drugs or alcohol in the last 5 years.

Suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events

Timeline

Screening/Baseline

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person) for consent, daily electronic diary entries

Treatment

Participants receive 12 intranasal treatments to the SPG over a period of 4 weeks

4 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 monthly phone visits, final in-person visit

Treatment Details

Interventions

• Tx360

Trial Overview The study tests the effectiveness of bupivacaine versus saline delivered through the Tx360® device to block nerve signals associated with chronic migraines. The treatment involves 12 intranasal applications over four weeks, followed by three months of follow-up assessments.

Participant Groups

Group I: Bupivacaine Active Control 1 Intervention

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

Group II: saline Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Tian Medical Inc.

Lead Sponsor

Trials

2

Recruited

220+

TAMM Net, Inc.

Collaborator

Trials

1

Recruited

170+

Clinvest Research, LLC

Industry Sponsor

Trials

3

Recruited

260+

Ki Health Partners. LLC

Industry Sponsor

Trials

3

Recruited

200+

Findings from Research

The sphenopalatine ganglion (SPG) block is an underutilized technique that has been effectively used to relieve various types of headaches, including chronic migraines and tension headaches, as well as moderate-to-severe back pain.

The report outlines three simple and cost-effective methodologies for performing the SPG block, which have shown positive results in pain relief for patients, highlighting its potential as a valuable tool in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Images in anesthesiology: three safe, simple, and inexpensive methods to administer the sphenopalatine ganglion block. Levin, D., Cohen, S.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360(®) as acute treatment for chronic migraine. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

Effectiveness of Greater Occipital Nerve Blocks in Migraine Prophylaxis. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

[The results of greater occipital nerve block applied for migraine headache]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Images in anesthesiology: three safe, simple, and inexpensive methods to administer the sphenopalatine ganglion block. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Atogepant: an emerging treatment for migraine. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacology of reflex blinks in the rat: a novel model for headache research. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

A role for brain cyclooxygenase-2 and prostaglandin-E2 in migraine: effects of nitroglycerin. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Platelet P2Y12 Inhibitor in the Treatment and Prevention of Migraine: A Systematic Review and Meta-Analysis. [2022]

10. Estonia pubmed.ncbi.nlm.nih.gov

Botulinum toxin type a therapy in migraine: preclinical and clinical trials. [2021]