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COMPLETED Phase 3

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

NCT03337620 · View on ClinicalTrials.gov ↗

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

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

1 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tian Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03337620 reports 11 study locations spanning 9 distinct geographic areas — top geographies include Connecticut, New York, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03337620?

The interventions under investigation include: Tx360 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03337620?

This trial is sponsored by Tian Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial