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NCT01709708 · ClinicalTrials.gov registry record · Phase 4
Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
A Phase 4 study, sponsored by Tian Medical.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
NCT01709708 is a Phase 4 study that has completed, run by Tian Medical. The registered enrollment target is 41 participants.
The verdict
NCT01709708, a Phase 4 study, has completed, sponsored by Tian Medical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
Study Summary
Migraine imposes a substantial burden on patients in terms of diminished daily functioning, quality of life, and financial loss. Pain severity and duration correlates with reduced measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG) has been implicated in a variety of cephalalgias. This has been well represented in the literature dating back over a century. Access to this structure can be gained via a small area of mucosa just posterior and superior to the tail of the middle turbinate on the lateral nasal wall. At this aspect, there is no bony boundary to the SPG. Blocking the SPG using local anesthetics relieves pain. Unfortunately, many current interventions are cumbersome, invasive, and expensive. The purpose of this study is to evaluate the efficacy of the Tx360™, a new nasal applicator device, in the treatment of head and face pain and to examine the economic implications. The Tx360™ is a single use device designed to deliver a topical local anesthetic to the specific area of mucosa associated with the SPG. A total of 42 study participants will be accepted into this double-blind placebo-controlled study. 28 will receive SPG blocks using a 0.3 mL of a 0.5% solution of Marcaine delivered by the Tx360™ while 14 will receive a placebo of saline substituted for the Marcaine. Both patient sets will also be given a piece of lemon hard candy as a taste distractor. Participants must have a chronic migraine history with over 15 symptomatic days per month over the past three months. The treatment plan consists of six weeks of treatment, two times per week. Short and longer term assessments will be retrieved and analyzed as detailed in the Study Design.
Interventions
- DRUG Saline
- DRUG Marcaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01709708
The ClinicalTrials.gov registry entry for NCT01709708 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tian Medical, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT01709708 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01709708 about?
NCT01709708 is a clinical study titled "Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine". Migraine imposes a substantial burden on patients in terms of diminished daily functioning, quality of life, and financial loss. Pain severity and duration correlates with reduced measures of daily functioning, and overall health status. The sphenopalatine ganglion (SPG) has been implicated in a var...
What is the current status of trial NCT01709708?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2012-09. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01709708?
The interventions under investigation include: Saline (DRUG), Marcaine (DRUG).
Who is sponsoring clinical trial NCT01709708?
This trial is sponsored by Tian Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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