Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      42 study participants will be included in this double-blind placebo-controlled study.
      Following enrollment of 42 subjects and completion of the 6-week Treatment Period by all
      active subjects, an analysis of the treatment effect will be performed for a reassessment of
      sample size and, if deemed appropriate, the study will continue with enrollment of additional
      subjects to ensure a more statistically robust interpretation of the data. The results of the
      statistical analysis will be blinded from Investigators and coordinators. The procedure will
      be delivered to all subjects who agree to participate, meet inclusion criteria, and sign
      informed consent.

      At Visit 1 following Informed Consent, a physical exam and vital signs will be completed. A
      medical, headache, and medication history (to include age, sex, height and weight, and
      duration and location of headache pain, as well as history of ER visits) will be collected on
      all subjects. Eligible subjects will be provided with a Baseline Headache Diary and
      instructed to treat migraines for the following month in their usual manner with their usual
      treatment. The daily Diary will document headache, acute treatment and response, and migraine
      associated symptoms (nausea, vomiting, light sensitivity, or sound sensitivity) to establish
      a Baseline number of headache days and severity. Visit 2 will be scheduled for 1 month
      following Visit 1. Following Visit 1, Visits 2-13 (treatment visits) will be scheduled to
      occur twice weekly (during the regular Monday - Friday work week) at least 2 days apart.
      Treatments should not occur on consecutive days.

      At Visit 2, the Baseline Headache Diary will be reviewed and those subjects continuing to
      meet eligibility will be dispensed a 6-week Treatment Period Diary and complete Before
      Procedure questions to include the Pain Intensity Numeric Rating Scale (NRS), the Modified
      Pain Characteristic Questionnaire, and a baseline Headache Impact Test-6 (HIT-6), have vital
      signs completed, and the medical, headache, and medication history updated. Subjects will be
      randomized 2:1 to Group A or Group B. Group A will receive treatment with 0.3 mL of 0.5%
      Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the SPG.
      Group B will receive saline substituted for Marcaine delivered bilaterally with the Tx360TM
      device to the mucosa associated with the SPG.

      To maintain the blinding of the treatment groups, neither the Investigator nor research
      personnel who are involved in evaluating the subject should prepare the study medication. An
      independent research staff person with no involvement in the study conduct will place study
      medication (either Marcaine for a subject randomized to Group A or Placebo/saline for a
      subject randomized to Group B) in a 1cc Luer Lok tip syringe and assemble the syringe and
      Tx360TM catheter as instructed in training. A label with the subject Drug Number will be
      placed on the device at that time. The research staff person administering the study
      medication will verify that the Drug Number assignment is correct.

      Both Groups will be given a piece of lemon hard candy as a taste distractor.

      At each treatment visit (Visits 2-13), in addition to Before Procedure questions, subjects
      will complete 15-minute and 30-minute After Procedure questionnaires to include the NRS and,
      at 30 minutes, the Patient's Global Impression of Change (PGIC). Subjects will take home a
      questionnaire to include the NRS, PGIC, satisfaction question, and the Modified Pain
      Characteristic Questionnaire to be completed at 24 hours following treatment and be
      instructed to return the 24-hour After Procedure questionnaire to the clinic at the next
      visit.

      At Visits 2-15 vital signs will be completed, medications will be updated, and Non-Serious
      Adverse Events will be collected after the first treatment. Serious Adverse Events will be
      collected once the informed consent has been signed and throughout the study.

      At Visits 5, 8, and 11, the Treatment Period Headache Diary will be collected, reviewed, and
      re-dispensed.

      At Visit 13, the 1-Month Post-Treatment Period Diary will be dispensed.

      The subject will return to the clinic at Visit 14 between 24 and 96 hours following the final
      treatment at Visit 13 to return the 24-hour After Procedure Questionnaire and complete the
      1-Month Treatment Period HIT-6. The Treatment Period Diary will be collected.

      At Visit 15, 1 month following the final treatment, each subject will return to the clinic
      and complete a 1-Month Follow Up HIT-6 and the 1-Month Follow Up Questionnaire. The 1-Month
      Post-Treatment Period Diary will be collected.

      At 6 months following the final treatment, each subject will be phoned to complete the
      6-Month Follow Up Questionnaire to include the NRS, PGIC, satisfaction question, the Modified
      Pain Characteristic Questionnaire, and a 6-Month Follow Up HIT-6.

      Treatment Medication Subjects randomized to Group A will be administered 0.3 mL of 0.5%
      Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the SPG.
      Twelve treatments will be administered over a period of 6 weeks.

      Subjects randomized to Group B will be administered saline substituted for Marcaine delivered
      bilaterally with the Tx360TM device to the mucosa associated with the SPG for treatment of
      chronic migraine. Twelve treatments will be administered over a period of 6 weeks.

      Rescue Medication Subjects will be allowed to rescue with medication mutually agreed upon by
      subject and Investigator at the time of screening.
    

Intervention name(s): Marcaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.; Saline
Other intervention name(s): Bupivicane (generic)
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine; Headache; Chronic Migraine; Marcaine; Tx360