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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: Completed Phase 3 study of Headache, Migraine, sponsored by Tian Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days during 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
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2023-12-29 |
| Phase | Phase 3 |
What the finished NCT03337620 record still lists
NCT03337620 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 229-participant average among 7 other Headache, Migraine trials with a reported enrollment target (24% lower).
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 lists 11 locations in 9 states (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.
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