Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
NCT ID: NCT01709708
Last Updated: 2018-01-26
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
41 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-09-30
Study Completion Date
2014-02-28
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Chronic Migraine
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Marcaine
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 Sphenopalatine Ganglion (SPG)
Group Type
ACTIVE_COMPARATOR
Marcaine
Intervention Type
DRUG
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
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
Group Type
PLACEBO_COMPARATOR
Saline
Intervention Type
DRUG
Saline
Interventions
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Marcaine
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.
Intervention Type
DRUG
Saline
Saline
Intervention Type
DRUG
Other Intervention Names
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Bupivicane (generic)
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Clinvest
OTHER
Sponsor Role
collaborator
Tian Medical Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Tian Xia, MD
Role: PRINCIPAL_INVESTIGATOR
Tian Medical Inc.
Locations
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Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Site Status
Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri, United States
Site Status
Countries
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United States
References
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Tepper SJ. A pivotal moment in 50 years of headache history: the first American Migraine Study. Headache. 2008 May;48(5):730-1; discussion 732. doi: 10.1111/j.1526-4610.2008.01117_1.x.
Reference Type
BACKGROUND
Piagkou M, Demesticha T, Troupis T, Vlasis K, Skandalakis P, Makri A, Mazarakis A, Lappas D, Piagkos G, Johnson EO. The pterygopalatine ganglion and its role in various pain syndromes: from anatomy to clinical practice. Pain Pract. 2012 Jun;12(5):399-412. doi: 10.1111/j.1533-2500.2011.00507.x. Epub 2011 Sep 29.
Reference Type
BACKGROUND
Oluigbo CO, Makonnen G, Narouze S, Rezai AR. Sphenopalatine ganglion interventions: technical aspects and application. Prog Neurol Surg. 2011;24:171-179. doi: 10.1159/000323049. Epub 2011 Mar 21.
Reference Type
BACKGROUND
Windsor RE, Jahnke S. Sphenopalatine ganglion blockade: a review and proposed modification of the transnasal technique. Pain Physician. 2004 Apr;7(2):283-6.
Reference Type
BACKGROUND
Rosenberg M, Phero JC. Regional anesthesia and invasive techniques to manage head and neck pain. Otolaryngol Clin North Am. 2003 Dec;36(6):1201-19. doi: 10.1016/s0030-6665(03)00134-8.
Reference Type
BACKGROUND
Wood PB. Role of central dopamine in pain and analgesia. Expert Rev Neurother. 2008 May;8(5):781-97. doi: 10.1586/14737175.8.5.781.
Reference Type
BACKGROUND
Boivie J. Chapter 48 Central post-stroke pain. Handb Clin Neurol. 2006;81:715-30. doi: 10.1016/S0072-9752(06)80052-7. No abstract available.
Reference Type
BACKGROUND
Stankewitz A, Voit HL, Bingel U, Peschke C, May A. A new trigemino-nociceptive stimulation model for event-related fMRI. Cephalalgia. 2010 Apr;30(4):475-85. doi: 10.1111/j.1468-2982.2009.01968.x. Epub 2010 Feb 1.
Reference Type
BACKGROUND
Herrera Tolosana S, Fernandez Liesa R, Escolar Castellon Jde D, Perez Delgado L, Lisbona Alquezar MP, Tejero-Garces Galve G, Guallar Larpa M, Ortiz Garcia A. [Sphenopalatinum foramen: an anatomical study]. Acta Otorrinolaringol Esp. 2011 Jul-Aug;62(4):274-8. doi: 10.1016/j.otorri.2011.01.009. Epub 2011 Mar 22. Spanish.
Reference Type
BACKGROUND
Rusu MC. Microanatomy of the neural scaffold of the pterygopalatine fossa in humans: trigeminovascular projections and trigeminal-autonomic plexuses. Folia Morphol (Warsz). 2010 May;69(2):84-91.
Reference Type
BACKGROUND
Oomen KP, Ebbeling M, de Ru JA, Hordijk GJ, Bleys RL. A previously undescribed branch of the pterygopalatine ganglion. Am J Rhinol Allergy. 2011 Jan-Feb;25(1):50-3. doi: 10.2500/ajra.2011.25.3550.
Reference Type
BACKGROUND
Siessere S, Vitti M, Sousa LG, Semprini M, Iyomasa MM, Regalo SC. Anatomic variation of cranial parasympathetic ganglia. Braz Oral Res. 2008 Apr-Jun;22(2):101-5. doi: 10.1590/s1806-83242008000200002.
Reference Type
BACKGROUND
Gronseth G, Cruccu G, Alksne J, Argoff C, Brainin M, Burchiel K, Nurmikko T, Zakrzewska JM. Practice parameter: the diagnostic evaluation and treatment of trigeminal neuralgia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the European Federation of Neurological Societies. Neurology. 2008 Oct 7;71(15):1183-90. doi: 10.1212/01.wnl.0000326598.83183.04. Epub 2008 Aug 20.
Reference Type
BACKGROUND
Yang lY, Oraee S. A novel approach to transnasal sphenopalatine ganglion injection. Pain Physician. 2006 Apr;9(2):131-4.
Reference Type
BACKGROUND
Kanai A, Suzuki A, Kobayashi M, Hoka S. Intranasal lidocaine 8% spray for second-division trigeminal neuralgia. Br J Anaesth. 2006 Oct;97(4):559-63. doi: 10.1093/bja/ael180. Epub 2006 Aug 1.
Reference Type
BACKGROUND
Cady RK, Saper J, Dexter K, Cady RJ, Manley HR. Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine. Headache. 2015 Apr;55(4):529-42. doi: 10.1111/head.12546. Epub 2015 Mar 31.
Reference Type
DERIVED
Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub 2014 Oct 23.
Reference Type
DERIVED
Related Links
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http://www.tianmedical.com
Instructions for use and device training
Other Identifiers
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12-004TI
Identifier Type: -
Identifier Source: org_study_id
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