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Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine

Primary Purpose

Headache, Migraine

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tx360
Sponsored by
Tian Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache, Migraine focused on measuring chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects may be included that meet the following criteria:

    1. willing to participate and sign informed consent
    2. ability to understand informed consent and study procedures, including able to use the electronic Daily Headache Diary
    3. in general good health based on investigator's judgment
    4. male or female, age must be between 18 to 65 years of age, inclusive
    5. chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013), as follows:

      1. History of frequent headaches suggestive of chronic migraine (at least 15 days per month with 8 or more being migraine) for at least three months prior to screening
      2. Verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase demonstrating headaches at least 15 days, with at least 8 days per month fulfilling any one of the following

        1. Qualify as being a migraine
        2. Relieved by migraine specific acute medications
    6. onset of migraine before age 50
    7. able to differentiate migraine from any other headache they may experience (e.g., tension-type headache)
    8. stable history of migraine at least 3 months prior to screening with headache free periods
    9. not currently taking a migraine preventive OR has been taking a stable dose of a preventive for at least 60 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period

      a) subjects on migraine preventative should have stable headache pattern

    10. subject is either not of childbearing potential, as defined in the methods section, or if they are of childbearing potential they agree either to remain abstinent or use (or have their partner use) an acceptable method of birth control for the duration of the study
    11. demonstrated compliance with the electronic Daily Headache Diary during the 28-day screening/baseline phase as defined by entry of headache data on a minimum of 22 to 28 days (80% diary compliance) in or completing the study.

Exclusion Criteria:

Subjects will be excluded that meet the following criteria:

  1. unable to complete headache records (diary) as required by protocol
  2. pregnant, actively trying to become pregnant, or breast-feeding
  3. history of medication overuse (MO) of opioids, or butalbital, as defined by ICHD-III beta criteria in the previous 12 months and/or MO during 28-day screening/baseline phase (Appendix B).
  4. history of hemiplegic migraine, basilar migraine, cervicogenic headache, occipital neuralgia or post-traumatic headache as defined by ICHD-III beta criteria (Post traumatic headache needs to have developed within 7 days of the following: injury to the head, regaining of consciousness following injury to the head, or discontinuation of medications that impair ability to send or report headache following the injury to the head.
  5. has failed greater than 2 migraine preventative medications due to lack of efficacy after adequate trial
  6. received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 4 months before screening.
  7. has a planned military deployment within the 6 months post screening
  8. has previously received SPG blocks using the Tx360®device
  9. history of substance abuse and/or dependence within the past 5 years, in the judgment of the Investigator
  10. unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure, in the judgment of the investigator
  11. suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events, in the judgment of the investigator
  12. any psychiatric condition with psychotic features, and/or any other psychiatric disorder not stable or well controlled, that would interfere in the ability to complete study activities
  13. malignancy within the past year, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
  14. nasal septal deformity such as cleft lip and palate, choanal atresia, atrophic rhinitis, rhinitis, or septal perforation
  15. recent nasal/midface trauma (< 3 months)
  16. nasal or facial fracture
  17. recent nasal/sinus surgery (< 3 months)
  18. bleeding disorder such as Von Willebrand disease or hemophilia
  19. severe respiratory distress
  20. neoplasm such as Angiofibroma, sinus tumor, granuloma
  21. nasal congestion present more than 10 days with fever (temperature ≥ 100.4 F) and nasal mucous is an abnormal color
  22. skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding
  23. recurrent nose bleeds
  24. allergy to bupivacaine
  25. has a score > 0 on question 9 of PHQ-9 at any visit
  26. received any investigational agents within 30 days prior to Visit 1
  27. plans to participate in another clinical study at any time during this study
  28. have any other conditions that in the judgment of the Investigator would make the subject unsuitable for inclusion, or would interfere with the subject participating

Sites / Locations

  • Yale University
  • New England Institute for Clinical ResearchRecruiting
  • Eisenhower Army Medical Center
  • Crescent City Headache and Neurology Centre
  • MedVadis Research
  • Clinvest Research, LLC
  • Hudson Medical
  • North Suffolk Neurology, PC
  • Womack Army Medical Senter
  • Preferred Primary Care Physicians
  • Lone Star NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

saline

Arm Description

Bupivacaine is a local anesthestic that will be delivered to the SPG by the Tx360 device.

Saline is being used as a placebo treatment that will be delivered to the SPG by the Tx360 device.

Outcomes

Primary Outcome Measures

Change in Number of Migraine Headaches During Treatment Phase
Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days during treatment.

Secondary Outcome Measures

Change in Number of Migraine Headache Days Post-Treatment
Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days post-treatment.
Safety/Tolerability of TX360 Device Based on Adverse Effects
Evaluate the safety and tolerability of the Tx360® device in the prevention of chronic migraine based on reported adverse effects.

Full Information

First Posted
October 20, 2017
Last Updated
May 18, 2023
Sponsor
Tian Medical Inc.
Collaborators
TAMM Net, Inc., Clinvest Research, LLC, Ki Health Partners. LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03337620
Brief Title
Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel 20 Week Study of the Efficacy and Safety of the Tx360® Nasal Applicator for Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tian Medical Inc.
Collaborators
TAMM Net, Inc., Clinvest Research, LLC, Ki Health Partners. LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a double blind placebo-controlled study which will evaluate the efficacy of bupivacaine compared to saline, delivered by the Tx360® device to the sphenopalatine ganglion (SPG), to treat chronic migraine headache. The Tx360® is a nasal applicator which is cleared through the FDA for transnasal medication delivery, including delivery to the SPG. The SPG has been implicated in a variety of cephalalgias. It is critical to the success of this intervention that the blocking agent be accurately delivered to this area as it is the only non-bony access to the pterygopalatine fossa (PPF). Subjects meeting inclusion/exclusion criteria will receive 12 intranasal treatments to the SPG over a period of 4 weeks with follow-up monthly for an additional 3 months post-treatment.
Detailed Description
This is a phase III, multi-center, randomized, double-blind, placebo-controlled, prospective, clinical trial examining the outcomes of subjects with chronic migraine headache who are treated with 0.3cc of 0.5% bupivacaine bilaterally vs 0.3cc of sterile water bilaterally, each delivered to the mucosal surface of the SPG through each nare with the Tx360® device. Subjects must have a current history of ICHD-III beta migraine with > 14 headache days per month (with 8 or more being migraine) in the 3 months prior to the screening visit. Subjects will be required to have a stable history of doses of migraine prophylactic medication for at least 30 days prior to the start of the 28-day screening/baseline phase and for the duration of the study. At Visit 1, the subject will sign the informed consent indicating they are willing to participate in the study. Initially, subjects who meet the study criteria will participate in a 28-day screening/baseline phase. During the 28-day screening/baseline phase, all subjects will be monitored through the use of electronic Daily Headache Diary (DHD) to ensure they continue to meet all inclusion criteria, and none of the exclusion criteria. If baseline criteria have been met at the end of the 28-day screening/baseline phase, the subject will return to the clinic for Visit 2 to be randomized into one of the two treatment groups and begin the 4-week treatment phase of the study. Subjects who meet all inclusion criteria, and none of the exclusion criteria, will be assigned to a treatment group based on a computerized randomization number produced by a computer software system. One hundred and eighty subjects will be randomized 1:1 to receive 0.3cc of 0.5% bupivacaine bilaterally or 0.3cc of sterile water bilaterally. One member of the staff will allocate study medication, based on the randomization plan, in a blinded fashion to subject, coordinator, and investigator. At Visit 2, the subject will receive the first treatment. The subject will return to the clinic three times per week for treatments, totaling 12 treatments. At visit 13, subjects will receive the last treatment and will be transitioned into the post-treatment phase of the study. The subject will be followed for an additional 3 months during the post-treatment phase for a total of 20 weeks participation in the study. During this post-treatment phase, the subject will maintain the DHD at an 80% participation rate and two monthly phone visits will take place 1 and 2 months post treatment respectively. The subject will complete the study at Visit 14 to the clinic for final follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multi-center, double blind, parallel, prospective, randomized; 28 days of screening; 4 weeks active treatment; 3 months of follow-up post-treatment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The subject, investigator, study coordinator, and additional study staff will remain blinded. One member of the staff will assign subjects to a treatment group based on a computerized randomization number produced by a computer software system. The number will correspond to a kit number, of which the staff member will then use to prepare the Tx360® device for each of the subject's treatments during the 4-week treatment phase. If the clinical site has a pharmacy, it is preferred that the pharmacy receive the study medication and Tx360® devices, maintain custody of the study medication and Tx360® devices during the study, and prepared the medication in Tx360® devices for each subject's treatment, according to the computer-generated randomization. In order to maintain subject-blinding during the active phase of the study, subjects will be given a piece of lemon candy prior to each procedure as a taste distractor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Bupivacaine is a local anesthestic that will be delivered to the SPG by the Tx360 device.
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
Saline is being used as a placebo treatment that will be delivered to the SPG by the Tx360 device.
Intervention Type
Device
Intervention Name(s)
Tx360
Intervention Description
Tx360 used to deliver active and placebo drug interventions to SPG.
Primary Outcome Measure Information:
Title
Change in Number of Migraine Headaches During Treatment Phase
Description
Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days during treatment.
Time Frame
From 28-day screening/baseline phase to the end of the 4-week treatment phase.
Secondary Outcome Measure Information:
Title
Change in Number of Migraine Headache Days Post-Treatment
Description
Evaluate the efficacy of bupivacaine delivered with the Tx360® device, based on the change in the number of migraine days post-treatment.
Time Frame
From 28-day screening/baseline to end of one month post-treatment, end of two months post-treatment, and end of three months post treatments (EOS)
Title
Safety/Tolerability of TX360 Device Based on Adverse Effects
Description
Evaluate the safety and tolerability of the Tx360® device in the prevention of chronic migraine based on reported adverse effects.
Time Frame
Measured per month from end of 28-day screening/baseline phase to end of the 4-week treatment phase, and end of one month post- treatment, end ot two months post-treatment, and end of 3 months post-treatment.(EOS)
Other Pre-specified Outcome Measures:
Title
Efficacy Evaluation Based on Change in Mean Headache Severity
Description
Evaluate the efficacy of bupivacaine vs sterile water delivered with the Tx360® device, based on the change in the mean headache severity.
Time Frame
Measured per month from end of 28-day screening/baseline phase to end of the 4-week treatment phase, and end of one month post- treatment, end ot two months post-treatment, and end of 3 months post-treatment.(EOS)
Title
Efficacy Evaluation Based on Change in Mean Number of Headache Days per Month
Description
Evaluate the efficacy of bupivacaine vs sterile water delivered with the Tx360® device, based on the change in the mean number of headache days per month.
Time Frame
Measured per month from end of 28-day screening/baseline phase to end of the 4-week treatment phase, and end of one month post- treatment, end ot two months post-treatment, and end of 3 months post-treatment.(EOS)
Title
Comparison of Response Rate
Description
Compare the response rate of those in bupivacaine vs sterile water delivered with the Tx360® device.
Time Frame
Measured per month from end of 28-day screening/baseline phase to end of the 4-week treatment phase, and end of one month post- treatment, end ot two months post-treatment, and end of 3 months post-treatment.(EOS)
Title
Comparison of Acute Medication Required
Description
Compare the need between treatment groups for acute medication based on number of doses of acute headache medication taken.
Time Frame
Measured per month from end of 28-day screening/baseline phase to end of the 4-week treatment phase, and end of one month post- treatment, end ot two months post-treatment, and end of 3 months post-treatment.(EOS)
Title
Evaluate Life Impact of Migraine Headaches
Description
Evaluate the impact of chronic migraine headaches on the subject's life (pain and disability) based on change in Migraine Disability Assessment (MIDAS) scores between treatment groups.
Time Frame
End of 28-day screening/baseline phase and end of 3 months post treatment.(EOS)
Title
Evaluate Disease Management Impact on Change in PROMIS Score
Description
Evaluate the subject's perceived impact of disease management based on change in Patient-Reported Outcomes Measurement Information System (PROMIS) scores between treatment groups.
Time Frame
Measured from end of 28-day screening/baseline phase and end of 3 months post treatment. (EOS) to end of treatment phase, and end of post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects may be included that meet the following criteria: willing to participate and sign informed consent ability to understand informed consent and study procedures, including able to use the electronic Daily Headache Diary in general good health based on investigator's judgment male or female, age must be between 18 to 65 years of age, inclusive chronic migraine meeting the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD-III beta version, 2013), as follows: History of frequent headaches suggestive of chronic migraine (at least 15 days per month with 8 or more being migraine) for at least three months prior to screening Verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase demonstrating headaches at least 15 days, with at least 8 days per month fulfilling any one of the following Qualify as being a migraine Relieved by migraine specific acute medications onset of migraine before age 50 able to differentiate migraine from any other headache they may experience (e.g., tension-type headache) stable history of migraine at least 3 months prior to screening with headache free periods not currently taking a migraine preventive OR has been taking a stable dose of a preventive for at least 60 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period a) subjects on migraine preventative should have stable headache pattern subject is either not of childbearing potential, as defined in the methods section, or if they are of childbearing potential they agree either to remain abstinent or use (or have their partner use) an acceptable method of birth control for the duration of the study demonstrated compliance with the electronic Daily Headache Diary during the 28-day screening/baseline phase as defined by entry of headache data on a minimum of 22 to 28 days (80% diary compliance) in or completing the study. Exclusion Criteria: Subjects will be excluded that meet the following criteria: unable to complete headache records (diary) as required by protocol pregnant, actively trying to become pregnant, or breast-feeding history of medication overuse (MO) of opioids, or butalbital, as defined by ICHD-III beta criteria in the previous 12 months and/or MO during 28-day screening/baseline phase (Appendix B). history of hemiplegic migraine, basilar migraine, cervicogenic headache, occipital neuralgia or post-traumatic headache as defined by ICHD-III beta criteria (Post traumatic headache needs to have developed within 7 days of the following: injury to the head, regaining of consciousness following injury to the head, or discontinuation of medications that impair ability to send or report headache following the injury to the head. has failed greater than 2 migraine preventative medications due to lack of efficacy after adequate trial received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 4 months before screening. has a planned military deployment within the 6 months post screening has previously received SPG blocks using the Tx360®device history of substance abuse and/or dependence within the past 5 years, in the judgment of the Investigator unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure, in the judgment of the investigator suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events, in the judgment of the investigator any psychiatric condition with psychotic features, and/or any other psychiatric disorder not stable or well controlled, that would interfere in the ability to complete study activities malignancy within the past year, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated nasal septal deformity such as cleft lip and palate, choanal atresia, atrophic rhinitis, rhinitis, or septal perforation recent nasal/midface trauma (< 3 months) nasal or facial fracture recent nasal/sinus surgery (< 3 months) bleeding disorder such as Von Willebrand disease or hemophilia severe respiratory distress neoplasm such as Angiofibroma, sinus tumor, granuloma nasal congestion present more than 10 days with fever (temperature ≥ 100.4 F) and nasal mucous is an abnormal color skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding recurrent nose bleeds allergy to bupivacaine has a score > 0 on question 9 of PHQ-9 at any visit received any investigational agents within 30 days prior to Visit 1 plans to participate in another clinical study at any time during this study have any other conditions that in the judgment of the Investigator would make the subject unsuitable for inclusion, or would interfere with the subject participating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelo Termine
Phone
203-914-1903
Ext
2
Email
angelo@neicr.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Griffin
Phone
203-914-1903
Ext
117
Email
carla@neinh.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tian Xia, MD
Organizational Affiliation
Tian Medical
Official's Role
Study Chair
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Terminated
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J McAllister
Phone
201-914-1900
Email
peter@neinh.com
First Name & Middle Initial & Last Name & Degree
Angelo Termine, MSM/MBA
Phone
203.914.1903 ext 3
Email
angelo@neicr.com
Facility Name
Eisenhower Army Medical Center
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905
Country
United States
Individual Site Status
Terminated
Facility Name
Crescent City Headache and Neurology Centre
City
Chalmette
State/Province
Louisiana
ZIP/Postal Code
70043
Country
United States
Individual Site Status
Terminated
Facility Name
MedVadis Research
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Terminated
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Individual Site Status
Terminated
Facility Name
Hudson Medical
City
New York
State/Province
New York
ZIP/Postal Code
10007
Country
United States
Individual Site Status
Terminated
Facility Name
North Suffolk Neurology, PC
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Terminated
Facility Name
Womack Army Medical Senter
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States
Individual Site Status
Terminated
Facility Name
Preferred Primary Care Physicians
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Individual Site Status
Terminated
Facility Name
Lone Star Neurology
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maushmi Sheth
Phone
214-619-1910
First Name & Middle Initial & Last Name & Degree
Alex Bannister
Phone
214-618-1636
Email
alex@lonestarneurology.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Tx360® Transnasal Sphenopalatine Ganglion Block in the Treatment of Chronic Migraine

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