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

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: March 11, 2014
Last verified: March 2014
  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
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:


Further study details as provided by Tian Medical Inc.:

Primary Outcome Measures:
  • Compare Numeric Rating Scale (NRS) score Before Procedure vs. 15-minute vs. 30-minute vs. 24-hour After Procedure scores for each of 12 treatments (Group A vs. Group B) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare change in Numeric Rating Scale (NRS) score from Before Procedure to 15-minute vs. Before Procedure to 30-minute vs. Before Procedure to 24-hour After Procedure scores for each of 12 treatments (Group A vs. Group B) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Compare 24-hour After Procedure Patient's Global Impression of Change (PGIC) score for each of 12 treatments (Group A vs. Group B) [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Compare Modified Brief Pain Inventory scores Before Procedure vs. 24-hour After Procedure vs. 1-Month Follow Up vs. 6-Month Follow Up Questionnaires for each of 12 treatments (Group A vs. Group B) [ Time Frame: 6 Months ] [ 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. [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Acute medications usage (type and dose) (Group A vs. Group B) [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Adverse effects (Group A vs. Group B) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • HIT-6 headache impact scores pre-treatment at Visit 2 vs. following final treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • Satisfaction questionnaire scores pre-treatment at Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B) [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]

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: Group A
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: Group B
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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:
Publications:

Responsible Party: Tian Medical Inc.
ClinicalTrials.gov Identifier: NCT01709708     History of Changes
Other Study ID Numbers: 12-004TI
Study First Received: October 16, 2012
Last Updated: March 11, 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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014