SPG Block with Tx360 for Chronic Migraine

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Tian Medical Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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

See 7 more

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

See 16 more

Treatment Details

Interventions

Tx360 (Other)

Trial OverviewThe 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

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.