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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Headache, Migraine
- Sponsor
- Tian Medical Inc.
- Enrollment
- 174
- Locations
- 11
- Primary Endpoint
- Change in Number of Migraine Headaches During Treatment Phase
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects may be included that meet the following criteria:
- •willing to participate and sign informed consent
- •ability to understand informed consent and study procedures, including able to use the electronic Daily Headache Diary
- •in general good health based on investigator's judgment
- •male or female, age must be between 18 to 65 years of age, inclusive
- •chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013), as follows:
- •History of frequent headaches suggestive of chronic migraine (at least 15 days per month with 8 or more being migraine) for at least three months prior to screening
- •Verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase demonstrating headaches at least 15 days, with at least 8 days per month fulfilling any one of the following
- •Qualify as being a migraine
- •Relieved by migraine specific acute medications
Exclusion Criteria
- •Subjects will be excluded that meet the following criteria:
- •unable to complete headache records (diary) as required by protocol
- •pregnant, actively trying to become pregnant, or breast-feeding
- •history of medication overuse (MO) of opioids, or butalbital, as defined by ICHD-III beta criteria in the previous 12 months and/or MO during 28-day screening/baseline phase (Appendix B).
- •history of hemiplegic migraine, basilar migraine, cervicogenic headache, occipital neuralgia or post-traumatic headache as defined by ICHD-III beta criteria (Post traumatic headache needs to have developed within 7 days of the following: injury to the head, regaining of consciousness following injury to the head, or discontinuation of medications that impair ability to send or report headache following the injury to the head.
- •has failed greater than 2 migraine preventative medications due to lack of efficacy after adequate trial
- •received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 4 months before screening.
- •has a planned military deployment within the 6 months post screening
- •has previously received SPG blocks using the Tx360®device
- •history of substance abuse and/or dependence within the past 5 years, in the judgment of the Investigator
Outcomes
Primary Outcomes
Change in Number of Migraine Headaches During Treatment Phase
Time Frame: From 28-day screening/baseline phase to the end of the 4-week treatment phase.
Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days during treatment.
Secondary Outcomes
- Change in Number of Migraine Headache Days Post-Treatment(From 28-day screening/baseline to end of one month post-treatment, end of two months post-treatment, and end of three months post treatments (EOS))
- Safety/Tolerability of TX360 Device Based on Adverse Effects(Measured per month from end of 28-day screening/baseline phase to end of the 4-week treatment phase, and end of one month post- treatment, end ot two months post-treatment, and end of 3 months post-treatment.(EOS))