SPG Block with Tx360 for Chronic Migraine

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with chronic migraines. It aims to determine if bupivacaine, a numbing medicine, can reduce migraine headaches when delivered through the nose using the Tx360 device, a specialized delivery device. Participants will receive 12 treatments over four weeks, and the study compares bupivacaine with a placebo, which contains no active medicine. The trial seeks individuals who have experienced migraines at least 15 days a month, with 8 of those days being migraines, for at least the last three months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new migraine treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using the Tx360 device to deliver bupivacaine to a specific area in the head has promising safety results. In studies, patients experienced headache relief soon after treatment, indicating effective performance. Importantly, these studies have not found any major safety issues with the treatment.

The FDA has already approved the Tx360 device for delivering medicine through the nose, providing extra reassurance about its safety. Bupivacaine, the medication being tested, is often used to numb specific areas and is known to be safe in various treatments.

In summary, research so far suggests that the treatment is well-tolerated by patients, with no major safety concerns reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic migraine?

Unlike the standard treatments for chronic migraine, which often include oral medications like triptans or daily preventative drugs, the Tx360 device delivers Bupivacaine, a local anesthetic, directly to the sphenopalatine ganglion (SPG). This delivery method is unique because it targets a key nerve center involved in migraine pain, potentially offering faster relief. Researchers are excited because this precise approach could reduce side effects associated with systemic medications and provide quicker, more targeted relief for migraine sufferers.

What evidence suggests that the Tx360 device is effective for treating chronic migraine?

Research has shown that using bupivacaine in SPG (sphenopalatine ganglion) blocks can reduce the number of migraine days. One study found that participants experienced 6 fewer headache days over 6 months with this treatment. Patients who received bupivacaine also reported less impact from headaches on daily activities. In this trial, one group of participants will receive bupivacaine delivered directly to the SPG using the Tx360 device, which has shown promise as an effective treatment for chronic migraines. Overall, these findings suggest that bupivacaine delivered through the Tx360 device could be a helpful option for people with chronic migraines. ^{5 6 7 8 9}

Who Is on the Research Team?

Tian Xia, MD

Principal Investigator

Tian Medical

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25828648/

Long-term efficacy of a double-blind, placebo-controlled ... Data from this exploratory pilot study suggest that there may be long-term clinical benefits with the use of repetitive SPG blockades with bupivacaine ...

2. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.12546

Long‐Term Efficacy of a Double‐Blind, Placebo‐Controlled ... This study aims to determine if repetitive sphenopalatine ganglion (SPG) blockades with 0.5% bupivacaine delivered with the Tx360 device results in long-term ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25338927/

A double-blind, placebo-controlled study of repetitive ... SPG blockade with bupivacaine delivered repetitively for 6 weeks with the Tx360(®) device demonstrates promise as an acute treatment of headache in some ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03337620

Efficacy and Safety of Tx360® Transnasal Sphenopalatine ... 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 ...

5. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/1129-2377-15-S1-E6

EHMTI-0268. Long term efficacy of repetitive sphenopalatine ... There was a 6-day reduction in headache days for group A (p=.001) vs. a 2-day reduction for group B at 6 months (p=.09). HIT-6 scores were lower ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4320756/

A Double-Blind, Placebo-Controlled Study of Repetitive ... Statistically significant headache relief is noted at 15 and 30 minutes and sustained at 24 hours for SPG blockade with bupivacaine vs saline.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03337620

Efficacy and Safety of Tx360® Transnasal Sphenopalatine ... 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6681144/

Long‐Term Efficacy of a Double‐Blind, Placebo‐Controlled ... This study aims to determine if repetitive sphenopalatine ganglion (SPG) blockades with 0.5% bupivacaine delivered with the Tx360 device results in long‐term ...

9. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/abs/10.1111/head.12546

Long‐Term Efficacy of a Double‐Blind, Placebo‐Controlled ... This study aims to determine if repetitive sphenopalatine ganglion (SPG) blockades with 0.5% bupivacaine delivered with the Tx360® device ...