Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Tx360
Intervention type(s): Device
Intervention description(s): Tx360 used to deliver active and placebo drug interventions to SPG.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multi-center, double blind, parallel, prospective, randomized; 28 days of screening; 4 weeks active treatment; 3 months of follow-up post-treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic