Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Marcaine; Saline
Intervention description: 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
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Chronic Migraine; Marcaine; Tx360

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is male or female, in otherwise good health, 18 to 80 years of age.

          2. Has history of chronic migraine (with or without aura) according to the criteria
             proposed by the Headache Classification Committee of the International Headache
             Society for at least 3 months prior to enrollment.

          3. Has onset of migraine before age 50.

          4. Is able to differentiate migraine from any other headache they may experience (e.g.,
             tension-type headache).

          5. Is not currently taking a migraine preventive or has been taking preventive for at
             least 30 days prior to screening and agrees to not start, stop, or change medication
             and/or dosage during the study period.

          6. If female of childbearing potential, agrees to use, for the duration of the study, a
             medically acceptable form of contraception as determined by the Investigator.

               1. Complete abstinence from intercourse from 2 weeks prior to administration of
                  study drug throughout the study, and for a time interval after completion or
                  premature discontinuation from the study to account for elimination of the study
                  drug; or,

               2. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of
                  pregnancy); or,

               3. Sterilization of male partner; or,

               4. Intrauterine device with published data showing lowest expected failure rate is
                  less than 1% per year; or,

               5. Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus
                  spermicide) for a least 1 month prior to Visit 1 and throughout study; or,

               6. Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout
                  study.

          7. Has pain presentation in frontal, temporal, ophthalmic, maxillary, mandibular, facial,
             or intraoral location.

        Exclusion Criteria:

          1. Is male or female, in otherwise good health, 18 to 80 years of age.

          2. Has history of chronic migraine (with or without aura) according to the criteria
             proposed by the Headache Classification Committee of the International Headache
             Society for at least 3 months prior to enrollment.

          3. Has onset of migraine before age 50.

          4. Is able to differentiate migraine from any other headache they may experience (e.g.,
             tension-type headache).

          5. Is not currently taking a migraine preventive or has been taking preventive for at
             least 30 days prior to screening and agrees to not start, stop, or change medication
             and/or dosage during the study period.

          6. If female of childbearing potential, agrees to use, for the duration of the study, a
             medically acceptable form of contraception as determined by the Investigator.

               1. Complete abstinence from intercourse from 2 weeks prior to administration of
                  study drug throughout the study, and for a time interval after completion or
                  premature discontinuation from the study to account for elimination of the study
                  drug; or,

               2. Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of
                  pregnancy); or,

               3. Sterilization of male partner; or,

               4. Intrauterine device with published data showing lowest expected failure rate is
                  less than 1% per year; or,

               5. Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus
                  spermicide) for a least 1 month prior to Visit 1 and throughout study; or,

               6. Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout
                  study.

          7. Has pain presentation in frontal, temporal, ophthalmic, maxillary, mandibular, facial,
             or intraoral location.