What side effects are associated with this type of intervention?

Common treatments for migraines involving local anesthetics, such as Bupivacaine used in sphenopalatine ganglion blocks, can have side effects including nasal discomfort, numbness in the throat or mouth, and a bitter taste. More serious but rare side effects may include allergic reactions, dizziness, and in some cases, systemic toxicity leading to cardiovascular or central nervous system complications. It is important to discuss these potential side effects with a healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including neuromodulation devices and local anesthetics. For instance, the Tx360® device, which delivers bupivacaine to the sphenopalatine ganglion, is FDA-cleared for transnasal medication delivery. Additionally, neuromodulation devices like the remote electrical neuromodulation device and transcranial magnetic stimulation (TMS) have been approved for migraine treatment. These devices offer non-invasive options for patients who may not respond to or tolerate traditional pharmacological treatments.

What other types of research exist?

Promising novel alternatives to Bupivacaine for blocking nerve signals in the sphenopalatine ganglion for migraine treatment include Galcanezumab, a monoclonal antibody targeting CGRP, and neurostimulation techniques. These alternatives have shown efficacy in clinical trials and are being considered for patients who do not respond to traditional treatments.

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SPG Block with Tx360 for Chronic Migraine

Phase 3

Waitlist Available

Research Sponsored by Tian Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort or irritation in the nasal passage where the Tx360® device is used, allergic reactions to bupivacaine for those sensitive to it, and typical side effects from local anesthetics like numbness or mild dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Number of Migraine Headaches During Treatment Phase

Secondary study objectives

Change in Number of Migraine Headache Days Post-Treatment

Safety/Tolerability of TX360 Device Based on Adverse Effects

Other study objectives

Comparison of Acute Medication Required

Comparison of Response Rate

Efficacy Evaluation Based on Change in Mean Headache Severity

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: BupivacaineActive Control1 Intervention

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

Group II: salinePlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Migraine treatments work through various mechanisms to alleviate pain and reduce the frequency of attacks. Bupivacaine, a local anesthetic, blocks nerve signals in the sphenopalatine ganglion (SPG), which is involved in the trigeminal autonomic reflex, thereby reducing pain transmission. Sumatriptan, a triptan, causes vasoconstriction and inhibits neuronal activity, addressing both vascular and neural components of migraines. OnabotulinumtoxinA (Botox) is thought to prevent the release of pain-related neuropeptides. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific pathophysiology of their migraines, potentially improving outcomes and reducing recurrence.

Clinical and experimental effects of sumatriptan in humans.Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine.Critical analysis of the use of onabotulinumtoxinA (botulinum toxin type A) in migraine.