Tian Medical Inc.
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.
Headache, Migraine
Tx360
PHASE3
This is a phase III, multi-center, randomized, double-blind, placebo-controlled, prospective, clinical trial examining the outcomes of subjects with chronic migraine headache who are treated with 0.3cc of 0.5% bupivacaine bilaterally vs 0.3cc of sterile water bilaterally, each delivered to the mucosal surface of the SPG through each nare with the Tx360® device. Subjects must have a current history of ICHD-III beta migraine with \> 14 headache days per month (with 8 or more being migraine) in the 3 months prior to the screening visit. Subjects will be required to have a stable history of doses of migraine prophylactic medication for at least 30 days prior to the start of the 28-day screening/baseline phase and for the duration of the study. At Visit 1, the subject will sign the informed consent indicating they are willing to participate in the study. Initially, subjects who meet the study criteria will participate in a 28-day screening/baseline phase. During the 28-day screening/baseline phase, all subjects will be monitored through the use of electronic Daily Headache Diary (DHD) to ensure they continue to meet all inclusion criteria, and none of the exclusion criteria. If baseline criteria have been met at the end of the 28-day screening/baseline phase, the subject will return to the clinic for Visit 2 to be randomized into one of the two treatment groups and begin the 4-week treatment phase of the study. Subjects who meet all inclusion criteria, and none of the exclusion criteria, will be assigned to a treatment group based on a computerized randomization number produced by a computer software system. One hundred and eighty subjects will be randomized 1:1 to receive 0.3cc of 0.5% bupivacaine bilaterally or 0.3cc of sterile water bilaterally. One member of the staff will allocate study medication, based on the randomization plan, in a blinded fashion to subject, coordinator, and investigator. At Visit 2, the subject will receive the first treatment. The subject will return to the clinic three times per week for treatments, totaling 12 treatments. At visit 13, subjects will receive the last treatment and will be transitioned into the post-treatment phase of the study. The subject will be followed for an additional 3 months during the post-treatment phase for a total of 20 weeks participation in the study. During this post-treatment phase, the subject will maintain the DHD at an 80% participation rate and two monthly phone visits will take place 1 and 2 months post treatment respectively. The subject will complete the study at Visit 14 to the clinic for final follow-up.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 174 participants |
Masking : | QUADRUPLE |
Masking Description : | The subject, investigator, study coordinator, and additional study staff will remain blinded. One member of the staff will assign subjects to a treatment group based on a computerized randomization number produced by a computer software system. The number will correspond to a kit number, of which the staff member will then use to prepare the Tx360® device for each of the subject's treatments during the 4-week treatment phase. If the clinical site has a pharmacy, it is preferred that the pharmacy receive the study medication and Tx360® devices, maintain custody of the study medication and Tx360® devices during the study, and prepared the medication in Tx360® devices for each subject's treatment, according to the computer-generated randomization. In order to maintain subject-blinding during the active phase of the study, subjects will be given a piece of lemon candy prior to each procedure as a taste distractor |
Primary Purpose : | TREATMENT |
Official Title : | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel 20 Week Study of the Efficacy and Safety of the Tx360® Nasal Applicator for Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine |
Actual Study Start Date : | 2017-09-20 |
Estimated Primary Completion Date : | 2023-11-15 |
Estimated Study Completion Date : | 2023-12-29 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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