Bupivacaine for Migraine

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
MigraineTx360 - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether bupivacaine delivered by the Tx360® device to the sphenopalatine ganglion can effectively treat chronic migraine headaches, compared to saline. The Tx360® is a nasal applicator which is FDA approved for transnasal medication delivery, including delivery to the SPG. The SPG has been implicated in a variety of cephalalgias, and accurate delivery of the medication to this area is critical for the success of the intervention.

Eligible Conditions
  • Migraine

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 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)

Month 3
Evaluate Life Impact of Migraine Headaches
From 28-day screening/baseline phase to the end of the 4-week treatment phase.
Change in Number of Migraine Headaches During Treatment Phase
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)
Change in Number of Migraine Headache Days Post-Treatment
Month 3
Evaluate Disease Management Impact on Change in PROMIS Score
Month 3
Comparison of Acute Medication Required
Comparison of Response Rate
Efficacy Evaluation Based on Change in Mean Headache Severity
Efficacy Evaluation Based on Change in Mean Number of Headache Days per Month
Safety/Tolerability of TX360 Device Based on Adverse Effects

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Bupivacaine
1 of 2
saline
1 of 2

Active Control

Non-Treatment Group

180 Total Participants · 2 Treatment Groups

Primary Treatment: Bupivacaine · Has Placebo Group · Phase 3

Bupivacaine
Device
ActiveComparator Group · 1 Intervention: Tx360 · Intervention Types: Device
saline
Device
PlaceboComparator Group · 1 Intervention: Tx360 · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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)

Who is running the clinical trial?

Tian Medical Inc.Lead Sponsor
1 Previous Clinical Trials
41 Total Patients Enrolled
TAMM Net, Inc.UNKNOWN
Clinvest Research, LLCIndustry Sponsor
2 Previous Clinical Trials
85 Total Patients Enrolled
1 Trials studying Migraine
55 Patients Enrolled for Migraine
Ki Health Partners. LLCIndustry Sponsor
Tian Xia, MDStudy ChairTian Medical
1 Previous Clinical Trials
41 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
New York100.0%
What site did they apply to?
Hudson Medical100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%