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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: Completed Phase 4 study, sponsored by Tian Medical.
NCT01709708 is a Phase 4 study that has completed, run by Tian Medical. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.
Interventions
- DRUG Saline
- DRUG Marcaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
What the finished NCT01709708 record still lists
NCT01709708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT01709708 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01709708's enrollment target sits among peer trials
41 1390th of 2000 higher than 604 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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