Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03337620 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine

A Phase 3 study of Headache, Migraine, sponsored by Tian Medical.

Completed
Registry status
Phase 3
Development phase
174
Enrollment target
11
Study locations

NCT03337620 is a Phase 3 study of Headache, Migraine that has completed, run by Tian Medical. The registered enrollment target is 174 participants, below the 229-participant average among 7 other Headache, Migraine trials with a reported enrollment target (24% lower). The trial reports 11 study locations across 9 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03337620, a Phase 3 study of Headache, Migraine, has completed, sponsored by Tian Medical.

COMPLETED
Registry status
Phase 3
Development phase
174 participants
Enrollment target
11
Study locations

Study Summary

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 sphenopalatine ganglion (SPG), to treat chronic migraine headache. The Tx360® is a nasal applicator which is cleared through the FDA for transnasal medication delivery, including delivery to the SPG. The SPG has been implicated in a variety of cephalalgias. It is critical to the success of this intervention that the blocking agent be accurately delivered to this area as it is the only non-bony access to the pterygopalatine fossa (PPF). Subjects meeting inclusion/exclusion criteria will receive 12 intranasal treatments to the SPG over a period of 4 weeks with follow-up monthly for an additional 3 months post-treatment.

Conditions Studied

Headache, Migraine

Interventions

  • DEVICE Tx360

Study Locations (11)

Connecticut

  • Yale University - New Haven
  • New England Institute for Clinical Research - Stamford

New York

  • Hudson Medical - New York
  • North Suffolk Neurology, PC - Port Jefferson Station

Georgia

  • Eisenhower Army Medical Center - Fort Gordon

Louisiana

  • Crescent City Headache and Neurology Centre - Chalmette

Massachusetts

  • MedVadis Research - Watertown

Missouri

  • Clinvest Research, LLC - Springfield

North Carolina

  • Womack Army Medical Senter - Fort Bragg

Pennsylvania

  • Preferred Primary Care Physicians - Pittsburgh

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 2017-09-20
Est. Completion 2023-12-29
Phase Phase 3

Sponsor

Tian Medical

2 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03337620

The ClinicalTrials.gov registry entry for NCT03337620 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 229-participant average among 7 other Headache, Migraine trials with a reported enrollment target (24% lower). The listed sponsor is Tian Medical, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Headache, Migraine appearing as the primary indexed condition, and to 1 intervention - of which Tx360 is the first listed.

NCT03337620 reports 11 study locations spanning 9 distinct geographic areas - top geographies include Connecticut, New York, Georgia.

Frequently Asked Questions

What is clinical trial NCT03337620 about?

NCT03337620 is a clinical study titled "Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine". 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 sphenopalatine ganglion (SPG), to treat chronic migraine headache. The Tx360® is a nasal applicator which is cleared through the FDA for transnasa...

What is the current status of trial NCT03337620?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 174 participants. The study started on 2017-09-20. Estimated completion is 2023-12-29.

What conditions does trial NCT03337620 study?

This clinical trial studies the following conditions: Headache, Migraine.

What interventions are being tested in trial NCT03337620?

The interventions under investigation include: Tx360 (DEVICE).

Who is sponsoring clinical trial NCT03337620?

This trial is sponsored by Tian Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03337620 being conducted?

This trial has 11 study locations across Connecticut, Georgia, Louisiana, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Headache, Migraine

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Headache, Migraine

All registered trials for this condition

Connecticut

All trials with a study site in Connecticut

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.