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

This study has been completed.
Sponsor:
Collaborator:
Clinvest
Information provided by (Responsible Party):
Tian Medical Inc.
ClinicalTrials.gov Identifier:
NCT01709708
First received: October 16, 2012
Last updated: November 12, 2014
Last verified: November 2014
History of Changes
  Purpose
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.

Condition Intervention Phase
Chronic Migraine
 Drug: Marcaine
Drug: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Use of the Tx360 Nasal Applicator for Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine: A Double-blind Placebo-controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Tian Medical Inc.:

Primary Outcome Measures:
  • Numeric Rating Scale (NRS) [ Time Frame: Estimated 6 Weeks ] [ Designated as safety issue: No ]
    Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.


Secondary Outcome Measures:
  • Change in Numeric Rating Scale (NRS) [ Time Frame: Estimated 6 Weeks ] [ Designated as safety issue: No ]
    Compare change in Numeric Rating Scale (NRS) score from Before Procedure to 15-Minutes, Before Procedure to 30-Minutes, Before Procedure to 24-Hours After Procedure for all 12 treatments (Group A vs. Group B). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain.

  • Patient's Global Impression of Change (PGIC) [ Time Frame: Estimated 6 Weeks ] [ Designated as safety issue: No ]
    Compare 24-Hour After Procedure Patient's Global Impression of Change (PGIC) score for 12 treatments (Group A vs. Group B). PGIC is a likert scale ranging from 1 to 7 with 1 being very much improved and 7 being very much worse.

  • Modified Pain Characteristic Questionnaire [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Compare Modified Pain Characteristic Questionnaire scores Before Procedure vs. 24-Hour After Procedure, Before Procedure vs. 1-Month Follow Up, and Before Procedure vs. 6-Month Follow Up (Group A vs. Group B). The modified pain characteristic questionnaire is a series of 11 questions on a likert scale ranging from 0 to 10 with 0 being no pain or does not interfere and 10 being worst pain or completely interferes.

  • Migraine Headache Days [ Time Frame: Estimated 14 Weeks ] [ Designated as safety issue: No ]
    Compare change in the number of migraine headache days per month reported in Baseline Period Diary vs. Treatment Period Diary vs. Post-Treatment Period Diary.

  • Acute Medications Usage [ Time Frame: Estimated 10 Weeks ] [ Designated as safety issue: No ]
    Number of acute medications used during Treatment period (estimated 6 weeks) and Follow-Up (estimated 4 weeks) (Group A vs. Group B).

  • Adverse Events [ Time Frame: Estimated 14 weeks ] [ Designated as safety issue: No ]
    Number of adverse events over the entire length of study (Group A vs. Group B).

  • Headache Impact Test (HIT-6) [ Time Frame: Estimated 10 Weeks ] [ Designated as safety issue: No ]
    Headache Impact Test (HIT-6) scores Pre-Treatment at Visit 2 vs. Post-Treatment (following final treatment), and at 1-Month Post-Treatment (Group A vs. Group B). HIT-6 is a series of 6 likert scale questions ranging from 1 to 5 with 1 being never and 5 being always.

  • Overall Satisfaction [ Time Frame: Estimated 10 Weeks ] [ Designated as safety issue: No ]
    Satisfaction scores Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B). Satisfaction scores are a likert scale ranging from 1 to 5 with 1 being complete dissatisfaction and 5 being complete satisfaction.
Enrollment: 41
Study Start Date: September 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)
 Drug: 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.
Other Name: Bupivicane (generic)
Placebo Comparator: Saline
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
 Drug: Saline

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709708

Locations
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri, United States, 65807
Sponsors and Collaborators
Tian Medical Inc.
Clinvest
Investigators
Principal Investigator: Tian Xia, MD Tian Medical Inc.
  More Information

Additional Information:
Instructions for use and device training  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tian Medical Inc.
ClinicalTrials.gov Identifier: NCT01709708     History of Changes
Other Study ID Numbers: 12-004TI 
Study First Received: October 16, 2012
Results First Received: July 24, 2014
Last Updated: November 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Tian Medical Inc.:
Migraine
Headache
Chronic Migraine
Marcaine
Tx360

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 26, 2016