Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tian Medical Inc.
• Collaborator: Clinvest
• Treatments: Bupivacaine

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.